Mindray Module Operator’s Manual


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Mindray Module Operator’s Manual | Manualzz

BeneVision N1

Patient Monitor

Operator’s Manual

© Copyright 2017-2020 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

Release time: June 2020

Revision: 10.0

WARNING

Federal Law (USA) restricts this device to sale by or on the order of a physician or other practitioner licensed by U.S. state law to use or order the use of this device.

BeneVision N1 Patient Monitor Operator’s Manual I

II

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others.

Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

is the trademark, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners.

This posting serves as notice under 35 U.S.C.§287(a) for Mindray patents: http://www.mindrayna.com/patents.

Manufacturer’s Responsibility

Contents of this manual are subject to changes without prior notice.

Mindray is responsible for the effects on safety, reliability and performance of this product, only if:

■ all installation operations, expansions, changes, modifications and repairs of this product are conducted by

Mindray authorized personnel; the electrical installation of the relevant room complies with the applicable national and local requirements; the product is used in accordance with the instructions for use.

WARNING

Only skilled/trained clinical professionals should operate this equipment.

It is important for the hospital or organization that uses this equipment to perform a recommended service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

Service

Mindray maintains a network of service representatives and factory-trained distributors. Prior to requesting service, perform a complete operational check of the instrument to verify proper control settings. If operational problems continue to exist, contact Mindray service.

In North America contact the Service Department at (800) 288-2121, ext: 8116 for Technical Support or (201)

995-8000 for assistance in determining the nearest field service location.

Please include the instrument model number, the serial number, and a description of the problem with all requests for service.

Any questions regarding the warranty should be directed to the local sales or service representative.

BeneVision N1 Patient Monitor Operator’s Manual

Company Contact

Manufacturer:

Address:

Website:

E-mail Address:

Tel:

Fax:

Distributor:

Address:

Tel:

Website:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Mindray Building, Keji 12th Road South, High-tech Industrial Park, Nanshan,

Shenzhen 518057, P.R.China

www.mindray.com

[email protected]

+86 755 81888998

+86 755 26582680

Mindray DS USA, Inc.

800 MacArthur Boulevard, Mahwah, New Jersey, 07430 USA

1.800.288.2121, 1.201.995.8000

www.mindray.com

BeneVision N1 Patient Monitor Operator’s Manual III

Preface

Manual Purpose

This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.

This manual is based on the maximum configuration and therefore some contents may not apply to the product.

If you have any question, please contact Mindray.

This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained conveniently when needed.

Intended Audience

This manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures, practices and terminology as required for monitoring of patients.

Illustrations

All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on the patient monitor.

Conventions

Italic text is used in this manual to quote the referenced manuals, chapters, sections and formulas.

Bold text is used to indicate the screen texts and names of hard keys.

→ is used to indicate operational procedures.

IV BeneVision N1 Patient Monitor Operator’s Manual

Contents

1 Safety .................................................................................................................................................................................. 1 - 1

1.1 Safety Information ..........................................................................................................................................................................................1 - 1

1.1.1 Warnings ..............................................................................................................................................................................................1 - 1

1.1.2 Cautions ................................................................................................................................................................................................1 - 2

1.1.3 Notes ......................................................................................................................................................................................................1 - 2

1.2 Equipment Symbols .......................................................................................................................................................................................1 - 3

2 Equipment Introduction ................................................................................................................................................... 2 - 1

2.1 Indications for Use ..........................................................................................................................................................................................2 - 1

2.2 Equipment Features .......................................................................................................................................................................................2 - 1

2.3 Applied Parts .....................................................................................................................................................................................................2 - 1

2.4 Main Unit ............................................................................................................................................................................................................2 - 2

2.4.1 Front View ............................................................................................................................................................................................2 - 2

2.4.2 Left View ...............................................................................................................................................................................................2 - 3

2.4.3 Right View ............................................................................................................................................................................................2 - 4

2.4.4 Bottom View ........................................................................................................................................................................................2 - 4

2.5 Modular Rack ....................................................................................................................................................................................................2 - 4

2.5.1 Left View ...............................................................................................................................................................................................2 - 5

2.5.2 Right View ............................................................................................................................................................................................2 - 5

2.6 Dock .....................................................................................................................................................................................................................2 - 6

2.6.1 Left View ...............................................................................................................................................................................................2 - 6

2.6.2 Right View ............................................................................................................................................................................................2 - 6

2.6.3 Rear View ..............................................................................................................................................................................................2 - 7

2.7 External Parameter Modules .......................................................................................................................................................................2 - 7

2.8 Installation .........................................................................................................................................................................................................2 - 8

2.8.1 Installing the N1 or External Parameter Module into the Modular Rack .......................................................................2 - 8

2.8.2 Removing the N1 or External Parameter Module from the Modular Rack ...................................................................2 - 8

2.8.3 Installing the Modular Rack to the Dock ...................................................................................................................................2 - 9

2.8.4 Removing the Modular Rack from the Dock ...........................................................................................................................2 - 9

2.8.5 Installing the N1 to the Dock ........................................................................................................................................................2 - 9

2.8.6 Removing the N1 from the Dock .............................................................................................................................................. 2 - 10

2.9 N1 in Use with a Host Monitor ................................................................................................................................................................. 2 - 10

2.9.1 Connecting the N1 to the Host Monitor through the Module Rack ............................................................................ 2 - 10

2.9.2 Connecting the N1 to the Host Monitor through the Satellite Module Rack (SMR) .............................................. 2 - 11

2.9.3 Connecting the N1 to the Host Monitor through the Dock ............................................................................................ 2 - 11

2.10 N1 in Use with the Transport Dock ...................................................................................................................................................... 2 - 12

2.11 Input Devices ............................................................................................................................................................................................... 2 - 12

2.12 Printing Devices .......................................................................................................................................................................................... 2 - 12

3 Getting Started .................................................................................................................................................................. 3 - 1

3.1 Equipment Preparation Safety Information ..........................................................................................................................................3 - 1

3.2 Monitor Installation ........................................................................................................................................................................................3 - 2

3.2.1 Unpacking and Checking ...............................................................................................................................................................3 - 2

3.2.2 Environmental Requirements .......................................................................................................................................................3 - 2

BeneVision N1 Patient Monitor Operator’s Manual 1

3.3 Setting Up the Equipment ...........................................................................................................................................................................3 - 2

3.3.1 Connecting the AC Mains ..............................................................................................................................................................3 - 2

3.3.2 Connecting the Input Devices .....................................................................................................................................................3 - 3

3.3.3 Installing the External Parameter Module ...............................................................................................................................3 - 3

3.4 Turning on the Monitor ................................................................................................................................................................................3 - 3

3.5 Operation and Navigation ...........................................................................................................................................................................3 - 4

3.5.1 Using the Touchscreen ...................................................................................................................................................................3 - 4

3.5.2 Using the On-Screen Keyboard ...................................................................................................................................................3 - 4

3.5.3 Using the Barcode Reader .............................................................................................................................................................3 - 5

3.6 Screen Display ..................................................................................................................................................................................................3 - 5

3.6.1 On-screen Symbols ..........................................................................................................................................................................3 - 6

3.6.2 Dialogs ..................................................................................................................................................................................................3 - 7

3.6.3 Quick Keys of N1 ................................................................................................................................................................................3 - 7

3.7 Operating Modes ............................................................................................................................................................................................3 - 8

3.7.1 Monitoring Mode ..............................................................................................................................................................................3 - 8

3.7.2 Module Mode .....................................................................................................................................................................................3 - 8

3.7.3 Privacy Mode ......................................................................................................................................................................................3 - 8

3.7.4 Night Mode .........................................................................................................................................................................................3 - 9

3.7.5 Standby Mode ................................................................................................................................................................................. 3 - 10

3.7.6 Outdoor Mode ................................................................................................................................................................................ 3 - 10

3.7.7 Discharge Mode ............................................................................................................................................................................. 3 - 11

3.8 Configuring the Monitor ........................................................................................................................................................................... 3 - 11

3.8.1 Setting the Date and Time .......................................................................................................................................................... 3 - 11

3.8.2 Adjusting the Screen Brightness .............................................................................................................................................. 3 - 11

3.8.3 Adjusting the Key Volume .......................................................................................................................................................... 3 - 11

3.9 General Operation ....................................................................................................................................................................................... 3 - 11

3.9.1 Switching On or Off a Parameter ............................................................................................................................................. 3 - 12

3.9.2 Displaying Parameter Numerics and Waveforms .............................................................................................................. 3 - 12

3.9.3 Displaying the Parameter List ................................................................................................................................................... 3 - 12

3.9.4 Accessing Parameter Setup Dialogs ....................................................................................................................................... 3 - 12

3.9.5 Changing Measurement Colors ................................................................................................................................................ 3 - 12

3.9.6 Choosing a Screen ......................................................................................................................................................................... 3 - 13

3.9.7 Selecting the Big Numerics Screen .......................................................................................................................................... 3 - 13

3.10 Connecting the CMS ................................................................................................................................................................................. 3 - 13

3.11 Connecting the eGateway ...................................................................................................................................................................... 3 - 14

3.12 Connecting the Wireless Network ....................................................................................................................................................... 3 - 14

3.13 Disconnecting the Wireless Network ................................................................................................................................................. 3 - 14

3.14 Turning Off the Monitor .......................................................................................................................................................................... 3 - 14

4 Using the External Display ................................................................................................................................................ 4 - 1

4.1 Using the External Display ...........................................................................................................................................................................4 - 1

4.1.1 Connecting the N1 to the External Display .............................................................................................................................4 - 1

4.1.2 External Display Troubleshooting ..............................................................................................................................................4 - 1

4.1.3 Quick keys of the independent external display ...................................................................................................................4 - 2

4.1.4 Configuring the Displayed Quick Keys (only available when the N1 is used with the independent external display) ..............................................................................................................................................................................................4 - 3

4.2 Minitrends Screen ...........................................................................................................................................................................................4 - 3

4.2.1 Entering the Minitrends Screen ...................................................................................................................................................4 - 3

2 BeneVision N1 Patient Monitor Operator’s Manual

4.2.2 The Display of Minitrends Screen ................................................................................................................................................4 - 4

4.2.3 Viewing the Long Trends ...............................................................................................................................................................4 - 4

4.2.4 Setting Minitrends Parameters .....................................................................................................................................................4 - 5

4.2.5 Setting the Minitrend Length .......................................................................................................................................................4 - 5

4.2.6 Setting the Alarm Statistics Switch .............................................................................................................................................4 - 5

4.2.7 Setting the Alarm Statistics Duration .........................................................................................................................................4 - 5

4.2.8 Routine Vital/Baseline ......................................................................................................................................................................4 - 5

4.3 The OxyCRG Screen ........................................................................................................................................................................................4 - 6

4.3.1 Entering the OxyCRG Screen .........................................................................................................................................................4 - 6

4.3.2 The Display of the OxyCRG Screen .............................................................................................................................................4 - 6

4.3.3 OxyCRG Events ...................................................................................................................................................................................4 - 6

4.3.4 The Display of the ABD Event Area .............................................................................................................................................4 - 7

4.3.5 Setting OxyCRG Parameters ..........................................................................................................................................................4 - 7

4.3.6 Setting the Threshold of ABD Events .........................................................................................................................................4 - 7

4.3.7 Editing ABD Events ...........................................................................................................................................................................4 - 7

4.4 The Targeted Goal Screen ............................................................................................................................................................................4 - 7

4.4.1 Entering the Targeted Goal Screen .............................................................................................................................................4 - 8

4.4.2 The Display of the Targeted Goal Screen .................................................................................................................................4 - 8

4.4.3 Configuring the Targeted Goal Screen Layout .......................................................................................................................4 - 8

4.4.4 Operating the Targeted Goal Screen .........................................................................................................................................4 - 9

4.5 Remote View .....................................................................................................................................................................................................4 - 9

4.5.1 Entering the Remote View Screen ..............................................................................................................................................4 - 9

4.5.2 About the Remote View ..................................................................................................................................................................4 - 9

4.5.3 Adding a Bed .................................................................................................................................................................................... 4 - 10

4.5.4 Removing a Bed .............................................................................................................................................................................. 4 - 11

4.5.5 Displaying the Main Bed ............................................................................................................................................................. 4 - 11

4.5.6 Saving a Manual Event ................................................................................................................................................................. 4 - 11

4.5.7 Managing Alarms from Remote Devices ............................................................................................................................... 4 - 11

4.5.8 Resetting Alarms for Remote Devices ..................................................................................................................................... 4 - 11

4.5.9 Selecting Beds By Care Group ................................................................................................................................................... 4 - 11

4.5.10 Alarm Watch .................................................................................................................................................................................. 4 - 11

4.5.11 Auto Displaying the Alarm Bed .............................................................................................................................................. 4 - 12

4.6 Freezing Waveforms .................................................................................................................................................................................... 4 - 13

4.6.1 Freezing Waveforms ..................................................................................................................................................................... 4 - 13

4.6.2 Viewing Frozen Waveforms ....................................................................................................................................................... 4 - 13

4.6.3 Unfreezing Waveforms ................................................................................................................................................................. 4 - 13

4.6.4 Printing Frozen Waveforms ........................................................................................................................................................ 4 - 13

5 Managing Patients ............................................................................................................................................................ 5 - 1

5.1 Starting Monitoring a Patient .....................................................................................................................................................................5 - 1

5.2 Admitting a Patient ........................................................................................................................................................................................5 - 1

5.2.1 Entering the Patient Management Dialog ...............................................................................................................................5 - 1

5.2.2 Editing Patient Information ...........................................................................................................................................................5 - 1

5.2.3 Loading Patient Information from the CMS ............................................................................................................................5 - 2

5.2.4 Loading Patient Information from the ADT Server ...............................................................................................................5 - 2

5.3 Transferring Patient ........................................................................................................................................................................................5 - 3

5.4 Exporting Patient Data ..................................................................................................................................................................................5 - 3

5.5 Deleting Patient Data .....................................................................................................................................................................................5 - 3

5.6 Stopping a Parameter Measurement .......................................................................................................................................................5 - 3

BeneVision N1 Patient Monitor Operator’s Manual 3

5.7 Discharging a Patient ....................................................................................................................................................................................5 - 3

6 Alarms ................................................................................................................................................................................. 6 - 1

6.1 Alarm Introduction .........................................................................................................................................................................................6 - 1

6.2 Alarm Safety Information .............................................................................................................................................................................6 - 1

6.3 Understanding the Alarms ..........................................................................................................................................................................6 - 1

6.3.1 Alarm Categories ...............................................................................................................................................................................6 - 1

6.3.2 Alarm Priorities ..................................................................................................................................................................................6 - 1

6.3.3 Alarm Indicators ................................................................................................................................................................................6 - 2

6.3.4 Alarm Status Symbols ......................................................................................................................................................................6 - 3

6.4 Accessing On-screen Help for Technical Alarms (AlarmSight) .......................................................................................................6 - 3

6.5 Checking the Physiological Alarms List ..................................................................................................................................................6 - 3

6.6 Changing Alarm Settings .............................................................................................................................................................................6 - 3

6.6.1 Setting Parameter Alarm Properties ..........................................................................................................................................6 - 3

6.6.2 Changing the Alarm Volume ........................................................................................................................................................6 - 4

6.6.3 Setting the Auto Limits for New Patient Switch ....................................................................................................................6 - 4

6.6.4 Initiating Auto Alarm Limits ..........................................................................................................................................................6 - 5

6.6.5 Setting the Zero RR Delay Time ...................................................................................................................................................6 - 7

6.6.6 Switching On or Off V-Tach Latching ........................................................................................................................................6 - 7

6.6.7 Restoring the Default Alarm Settings ........................................................................................................................................6 - 7

6.6.8 Setting the Length of Printed Waveforms ...............................................................................................................................6 - 7

6.7 Pausing Alarms/Pausing Alarm Tones .....................................................................................................................................................6 - 8

6.7.1 Pausing Alarms ..................................................................................................................................................................................6 - 8

6.7.2 Pausing Alarm Sound ......................................................................................................................................................................6 - 8

6.8 Resetting Alarms .............................................................................................................................................................................................6 - 9

6.8.1 Resetting Physiological Alarms ....................................................................................................................................................6 - 9

6.8.2 Resetting Technical Alarms ...........................................................................................................................................................6 - 9

6.9 Latching Alarms ...............................................................................................................................................................................................6 - 9

6.10 CPB Mode ..................................................................................................................................................................................................... 6 - 10

6.10.1 Entering the CPB Mode ............................................................................................................................................................. 6 - 10

6.10.2 Exiting the CPB Mode ................................................................................................................................................................ 6 - 10

6.11 Intubation Mode ........................................................................................................................................................................................ 6 - 10

6.11.1 Entering the Intubation Mode ................................................................................................................................................ 6 - 10

6.11.2 Exiting the Intubation Mode ................................................................................................................................................... 6 - 10

6.12 Testing Alarms ............................................................................................................................................................................................ 6 - 11

7 Monitoring ECG, Arrhythmia, ST and QT ......................................................................................................................... 7 - 1

7.1 ECG Introduction .............................................................................................................................................................................................7 - 1

7.2 ECG Safety Information .................................................................................................................................................................................7 - 1

7.3 ECG Display .......................................................................................................................................................................................................7 - 2

7.4 Preparing for ECG Monitoring ....................................................................................................................................................................7 - 2

7.4.1 Preparing the Patient Skin .............................................................................................................................................................7 - 2

7.4.2 Applying Electrodes and Connecting the Patient ................................................................................................................7 - 2

7.4.3 Lead Wire Color Code ......................................................................................................................................................................7 - 3

7.4.4 ECG Electrode Placements .............................................................................................................................................................7 - 3

7.4.5 Choosing the ECG Lead Type .......................................................................................................................................................7 - 6

7.4.6 Checking Paced Status ....................................................................................................................................................................7 - 6

7.4.7 Enabling Pacer Rejection ...............................................................................................................................................................7 - 6

4 BeneVision N1 Patient Monitor Operator’s Manual

7.5 Changing ECG Settings .................................................................................................................................................................................7 - 7

7.5.1 Choosing an ECG Screen ................................................................................................................................................................7 - 7

7.5.2 Setting ECG Alarm Properties .......................................................................................................................................................7 - 7

7.5.3 Changing ECG Wave Settings .......................................................................................................................................................7 - 7

7.5.4 Disabling the Smart Lead Off Function .....................................................................................................................................7 - 9

7.5.5 Adjusting the QRS Volume ............................................................................................................................................................7 - 9

7.5.6 Adjusting the Minimum QRS Detection Threshold ..............................................................................................................7 - 9

7.6 Monitoring Arrhythmia .............................................................................................................................................................................. 7 - 10

7.6.1 Arrhythmia Safety Information ................................................................................................................................................. 7 - 10

7.6.2 Arrhythmia Events ......................................................................................................................................................................... 7 - 10

7.6.3 Displaying Arrhythmia Information ......................................................................................................................................... 7 - 11

7.6.4 Changing Arrhythmia Settings .................................................................................................................................................. 7 - 11

7.6.5 Intelligent Arrhythmia Alarm ..................................................................................................................................................... 7 - 13

7.7 ST Segment Monitoring ............................................................................................................................................................................. 7 - 15

7.7.1 ST Safety Information ................................................................................................................................................................... 7 - 15

7.7.2 Enabling ST Monitoring ............................................................................................................................................................... 7 - 15

7.7.3 Displaying ST Deviation Numerics ........................................................................................................................................... 7 - 15

7.7.4 Displaying ST Segments in the Waveform Area .................................................................................................................. 7 - 16

7.7.5 Entering the ST View ..................................................................................................................................................................... 7 - 17

7.7.6 Saving the Current ST Deviation and Segment as Baseline ............................................................................................ 7 - 17

7.7.7 Entering the ST Graphic (only available when the N1 is used with the independent external display) ........ 7 - 18

7.7.8 Changing ST Settings .................................................................................................................................................................... 7 - 18

7.7.9 Adjusting ST Measurement Points ........................................................................................................................................... 7 - 19

7.8 QT/QTc Interval Monitoring ..................................................................................................................................................................... 7 - 20

7.8.1 QT/QTc Monitoring Limitations ................................................................................................................................................ 7 - 20

7.8.2 Enabling QT/QTc Monitoring ..................................................................................................................................................... 7 - 20

7.8.3 Displaying QT Numerics and Segments ................................................................................................................................. 7 - 21

7.8.4 Entering the QT View .................................................................................................................................................................... 7 - 21

7.8.5 Saving the Current QTc as Baseline ......................................................................................................................................... 7 - 22

7.8.6 Changing QT Settings ................................................................................................................................................................... 7 - 22

7.9 ECG Relearning .............................................................................................................................................................................................. 7 - 22

7.9.1 Auto ECG Relearning ..................................................................................................................................................................... 7 - 22

7.9.2 Initiating an ECG Relearning Manually ................................................................................................................................... 7 - 23

7.10 Defibrillation Synchronization Pulse Output ................................................................................................................................... 7 - 23

7.11 ECG Troubleshooting ............................................................................................................................................................................... 7 - 23

8 Resting 12-Lead ECG Analysis .......................................................................................................................................... 8 - 1

8.1 Resting 12-Lead ECG Analysis Introduction ..........................................................................................................................................8 - 1

8.2 Entering the 12-Lead Screen .......................................................................................................................................................................8 - 1

8.3 Initiating Resting 12-Lead ECG Analysis ..................................................................................................................................................8 - 1

8.4 Changing 12-Lead ECG Analysis Settings ...............................................................................................................................................8 - 1

8.4.1 Setting the High Frequency Filter ...............................................................................................................................................8 - 1

8.4.2 Setting the Baseline Drift Removal Filter ..................................................................................................................................8 - 1

8.4.3 Setting the 12-Lead Waveform Layout .....................................................................................................................................8 - 2

8.4.4 Editing Patient Information ...........................................................................................................................................................8 - 2

8.4.5 Setting Tachycardia and Bradycardia Thresholds .................................................................................................................8 - 2

8.4.6 Setting the 12-Lead Interpretation Report .............................................................................................................................8 - 3

8.5 Saving the 12-Lead Interpretation Report .............................................................................................................................................8 - 3

BeneVision N1 Patient Monitor Operator’s Manual 5

8.6 Printing the 12-Lead Interpretation Report ...........................................................................................................................................8 - 3

8.7 Exiting the ECG 12-Lead Screen .................................................................................................................................................................8 - 3

9 Monitoring Impedance Respiration (Resp) ..................................................................................................................... 9 - 1

9.1 Resp Introduction ...........................................................................................................................................................................................9 - 1

9.2 Impedance Resp Safety Information ........................................................................................................................................................9 - 1

9.3 Resp Display ......................................................................................................................................................................................................9 - 2

9.4 Preparing for Impedance Resp Monitoring ...........................................................................................................................................9 - 2

9.4.1 Preparing the Patient ......................................................................................................................................................................9 - 2

9.4.2 Placing the Electrodes .....................................................................................................................................................................9 - 3

9.5 Changing Resp Settings ...............................................................................................................................................................................9 - 4

9.5.1 Setting the Resp Alarm Properties ..............................................................................................................................................9 - 4

9.5.2 Setting the RR Source .....................................................................................................................................................................9 - 4

9.5.3 Choosing the Respiration Lead ....................................................................................................................................................9 - 4

9.5.4 Setting the Resp Waveform Size .................................................................................................................................................9 - 4

9.5.5 Setting the Resp Waveform Speed .............................................................................................................................................9 - 4

9.5.6 Setting the Auto Detection Switch .............................................................................................................................................9 - 5

9.5.7 Adjusting the Resp Waveform Detection Threshold ...........................................................................................................9 - 5

10 Monitoring Pulse Oxygen Saturation (SpO

2

) ..............................................................................................................10 - 1

10.1 SpO

2

Introduction ..................................................................................................................................................................................... 10 - 1

10.2 SpO

2

Safety Information ......................................................................................................................................................................... 10 - 2

10.3 SpO

2

Measurement Limitations ........................................................................................................................................................... 10 - 3

10.4 SpO

2

Display ................................................................................................................................................................................................ 10 - 3

10.5 Preparing for SpO

2

Monitoring ............................................................................................................................................................ 10 - 4

10.6 Changing the SpO

2

Settings .................................................................................................................................................................. 10 - 4

10.6.1 Changing the SpO

2

Alarm Settings ...................................................................................................................................... 10 - 4

10.6.2 Nellcor SatSeconds

TM

Alarm Management ....................................................................................................................... 10 - 5

10.6.3 Setting SpO

2

Sensitivity (for Masimo SpO

2

) ...................................................................................................................... 10 - 6

10.6.4 Enabling FastSAT (for Masimo SpO

2

) ................................................................................................................................... 10 - 6

10.6.5 Displaying SIQ (for Masimo SpO

2

) ......................................................................................................................................... 10 - 7

10.6.6 Changing Averaging Time (for Masimo SpO

2

) ................................................................................................................. 10 - 7

10.6.7 Monitoring SpO

2

and NIBP Simultaneously ...................................................................................................................... 10 - 7

10.6.8 Changing the Sweep Speed of the Pleth Waveform ...................................................................................................... 10 - 7

10.7 Changing the PR Settings ....................................................................................................................................................................... 10 - 7

10.7.1 Changing the PR Alarm Settings ............................................................................................................................................ 10 - 7

10.7.2 Changing the QRS Volume ...................................................................................................................................................... 10 - 8

10.7.3 Setting the PR Source ................................................................................................................................................................ 10 - 8

10.7.4 Showing/Hiding PR ..................................................................................................................................................................... 10 - 8

10.8 Displaying SpO2 Statistics ...................................................................................................................................................................... 10 - 8

10.8.1 Selecting the Range of each SpO

2

Section and the Target Section .......................................................................... 10 - 9

10.8.2 Selecting the SpO

2

Statistics Length .................................................................................................................................... 10 - 9

10.9 SpO

2

Troubleshooting ............................................................................................................................................................................. 10 - 9

10.10 Nellcor Information .............................................................................................................................................................................10 - 10

10.11 Masimo Information .............................................................................................................................................................................10 - 10

10.12 Masimo End-User License Agreement .......................................................................................................................................... 10 - 10

11 Monitoring Temperature (Temp) ..................................................................................................................................11 - 1

6 BeneVision N1 Patient Monitor Operator’s Manual

11.1 Temperature Introduction ...................................................................................................................................................................... 11 - 1

11.2 .Temperature Safety Information ......................................................................................................................................................... 11 - 1

11.3 Temperature Display ................................................................................................................................................................................ 11 - 1

11.4 Preparing for Temperature Monitoring ............................................................................................................................................. 11 - 1

11.5 Changing Temperature Settings .......................................................................................................................................................... 11 - 2

11.5.1 Setting the Temperature Alarm Properties ........................................................................................................................ 11 - 2

11.5.2 Selecting the Temperature Label ........................................................................................................................................... 11 - 2

11.5.3 Displaying the Temperature Difference .............................................................................................................................. 11 - 2

11.6 Temperature Troubleshooting ............................................................................................................................................................. 11 - 2

12 Monitoring Noninvasive Blood Pressure (NIBP) .........................................................................................................12 - 1

12.1 NIBP Introduction ...................................................................................................................................................................................... 12 - 1

12.2 NIBP Safety Information .......................................................................................................................................................................... 12 - 1

12.3 NIBP Measurement Limitations ............................................................................................................................................................ 12 - 2

12.4 Measurement Modes ................................................................................................................................................................................ 12 - 2

12.5 NIBP Display ................................................................................................................................................................................................. 12 - 3

12.6 Preparing for NIBP Measurements ...................................................................................................................................................... 12 - 3

12.6.1 Preparing the Patient for NIBP Measurements ................................................................................................................. 12 - 3

12.6.2 Placing the NIBP Cuff .................................................................................................................................................................. 12 - 4

12.7 Starting and Stopping NIBP Measurements .................................................................................................................................... 12 - 4

12.8 Changing NIBP Settings ........................................................................................................................................................................... 12 - 5

12.8.1 Setting the NIBP Alarm Properties ......................................................................................................................................... 12 - 5

12.8.2 Setting the Initial Cuff Inflation Pressure ............................................................................................................................ 12 - 5

12.8.3 Setting the NIBP Interval ........................................................................................................................................................... 12 - 5

12.8.4 Selecting NIBP Start Mode ........................................................................................................................................................ 12 - 5

12.8.5 Enabling the NIBP End Tone .................................................................................................................................................... 12 - 5

12.8.6 Setting NIBP Sequence .............................................................................................................................................................. 12 - 6

12.8.7 Setting the NIBP Display Format ............................................................................................................................................ 12 - 6

12.8.8 Setting the NIBP Alarm Limits Display Switch ................................................................................................................... 12 - 6

12.8.9 Showing/Hiding PR ..................................................................................................................................................................... 12 - 6

12.8.10 Correcting the NIBP Measurements ................................................................................................................................... 12 - 6

12.9 Assisting Venous Puncture ..................................................................................................................................................................... 12 - 6

12.10 NIBP Troubleshooting ............................................................................................................................................................................ 12 - 7

13 Monitoring Invasive Blood Pressure (IBP) ...................................................................................................................13 - 1

13.1 IBP Introduction .......................................................................................................................................................................................... 13 - 1

13.2 IBP Safety Information .............................................................................................................................................................................. 13 - 1

13.3 Preparing for IBP Monitoring ................................................................................................................................................................. 13 - 2

13.3.1 IBP Equipment to Patient Connection ................................................................................................................................. 13 - 2

13.3.2 Measuring an Invasive Blood Pressure ................................................................................................................................. 13 - 2

13.3.3 Zeroing the IBP transducer ....................................................................................................................................................... 13 - 3

13.4 Measuring ICP Using the Codman ICP Transducer ........................................................................................................................ 13 - 3

13.4.1 Zeroing the Codman ICP transducer .................................................................................................................................... 13 - 3

13.4.2 Measuring ICP ............................................................................................................................................................................... 13 - 3

13.5 IBP Display .................................................................................................................................................................................................... 13 - 4

13.5.1 Overlapping IBP Waveforms .................................................................................................................................................... 13 - 4

13.6 Changing IBP Settings .............................................................................................................................................................................. 13 - 5

BeneVision N1 Patient Monitor Operator’s Manual 7

13.6.1 Changing the IBP Alarm Settings .......................................................................................................................................... 13 - 5

13.6.2 Changing the Pressure Label .................................................................................................................................................. 13 - 5

13.6.3 Setting the Pressure Type for Display .................................................................................................................................. 13 - 6

13.6.4 Changing the Sensitivity ........................................................................................................................................................... 13 - 6

13.6.5 Setting the IBP Waveform ........................................................................................................................................................ 13 - 6

13.6.6 Setting the Display Format of Artery Pressure .................................................................................................................. 13 - 7

13.6.7 Showing/Hiding the Alarm Limits of Artery Pressure .................................................................................................... 13 - 7

13.6.8 Setting the Use PA-D as PAWP Switch (only available when the N1 is used with the independent external display) ........................................................................................................................................................................................... 13 - 7

13.6.9 Enabling PPV Measurement .................................................................................................................................................... 13 - 7

13.7 PAWP (only available when the N1 is used with the independent external display) ....................................................... 13 - 7

13.7.1 PAWP Equipment to Patient Connection ........................................................................................................................... 13 - 8

13.7.2 Preparing to Measure PAWP ................................................................................................................................................... 13 - 8

13.7.3 Measuring PAWP ......................................................................................................................................................................... 13 - 9

13.7.4 Setting the Waveforms of the PAWP Screen ................................................................................................................... 13 - 10

13.7.5 Performing Hemodynamic Calculation (only available when the N1 is used with the independent external display) .........................................................................................................................................................................................13 - 10

13.8 IBP Troubleshooting ...............................................................................................................................................................................13 - 10

14 Monitoring Carbon Dioxide (CO

2

) ................................................................................................................................14 - 1

14.1 CO

2

Introduction ....................................................................................................................................................................................... 14 - 1

14.2 Identifying CO

2

Modules ........................................................................................................................................................................ 14 - 1

14.3 CO

2

Safety Information ........................................................................................................................................................................... 14 - 2

14.4 CO

2

Measurement Limitations ............................................................................................................................................................. 14 - 2

14.5 CO

2

Display .................................................................................................................................................................................................. 14 - 3

14.6 Measuring CO

2

Using the Sidestream/Microstream CO

2

Module ........................................................................................... 14 - 3

14.6.1 Preparing to Measure CO

2

Using the Sidestream CO

2

Module .................................................................................. 14 - 3

14.6.2 Preparing to Measure CO

2

Using the Microstream CO

2

Module ............................................................................... 14 - 5

14.6.3 Zeroing the Sidestream/Microstream CO

2

Module ........................................................................................................ 14 - 6

14.7 Changing Settings for All CO

2

Modules ............................................................................................................................................ 14 - 6

14.7.1 Changing CO

2

Alarm Settings ................................................................................................................................................ 14 - 6

14.7.2 Setting the CO

2

Waveform ....................................................................................................................................................... 14 - 6

14.7.3 Setting the RR Source ................................................................................................................................................................ 14 - 6

14.7.4 Entering the Standby Mode .................................................................................................................................................... 14 - 7

14.7.5 Entering the Intubation Mode ................................................................................................................................................ 14 - 7

14.7.6 Setting the Auto Standby ......................................................................................................................................................... 14 - 7

14.7.7 Setting Humidity Compensation ........................................................................................................................................... 14 - 7

14.8 Setting the Gas Compensation ............................................................................................................................................................. 14 - 8

14.9 Choosing a Time Interval for Peak-Picking ....................................................................................................................................... 14 - 8

14.10 Performing the Leakage Test .............................................................................................................................................................. 14 - 8

14.11 CO

2

Calibration ........................................................................................................................................................................................ 14 - 9

14.12 Test Method Used to Determine the Respiration Rate Measuring Range ......................................................................... 14 - 9

14.13 CO

2

Troubleshooting ............................................................................................................................................................................. 14 - 9

14.13.1 Troubleshooting the Sidestream/Microstream CO

2

Module .................................................................................... 14 - 9

14.14 Oridion Information ............................................................................................................................................................................... 14 - 9

15 Review ............................................................................................................................................................................15 - 1

15.1 Review Overview ....................................................................................................................................................................................... 15 - 1

8 BeneVision N1 Patient Monitor Operator’s Manual

15.2 Review Dialog .............................................................................................................................................................................................. 15 - 1

15.2.1 Accessing the Review Dialog ................................................................................................................................................... 15 - 1

15.2.2 Example Review Dialog ............................................................................................................................................................. 15 - 1

15.2.3 Symbols on Review Pages ........................................................................................................................................................ 15 - 2

15.2.4 Common Operations .................................................................................................................................................................. 15 - 2

15.2.5 Tabular Trends Review Page .................................................................................................................................................... 15 - 3

15.2.6 Graphics Trends Review Page ................................................................................................................................................. 15 - 4

15.2.7 Events Review Page .................................................................................................................................................................... 15 - 5

15.2.8 Full Disclosure Review Page .................................................................................................................................................... 15 - 6

15.2.9 OxyCRG Review Page (available when the N1 is used with the independent external display) .................... 15 - 8

15.2.10 12-Lead ECG Review Page ...................................................................................................................................................... 15 - 9

15.3 Reviewing Discharged Patients ............................................................................................................................................................ 15 - 9

15.3.1 Checking the Data of a Discharged Patient .....................................................................................................................15 - 10

15.3.2 Checking the Information of a Discharged Patient .......................................................................................................15 - 10

16 Clinical Assistive Applications (CAA) (available when the N1 is used with the independent external display) ....16 - 1

16.1 Checking Software Licenses ................................................................................................................................................................... 16 - 1

16.2 Early Warning Score (EWS) ...................................................................................................................................................................... 16 - 1

16.2.1 Displaying the EWS Numerics Area ....................................................................................................................................... 16 - 2

16.2.2 Accessing the EWS Screen ........................................................................................................................................................ 16 - 2

16.2.3 Performing EWS Scoring ........................................................................................................................................................... 16 - 3

16.2.4 Changing EWS Settings ............................................................................................................................................................. 16 - 4

16.2.5 Viewing Historical Scores .......................................................................................................................................................... 16 - 5

16.2.6 Viewing Parameter Trends ....................................................................................................................................................... 16 - 5

16.3 Glasgow Coma Scale (GCS) .................................................................................................................................................................... 16 - 5

16.3.1 Displaying the GCS Parameter Area ...................................................................................................................................... 16 - 6

16.3.2 Accessing the GCS Dialog ......................................................................................................................................................... 16 - 6

16.3.3 Performing GCS Scoring ............................................................................................................................................................ 16 - 7

16.3.4 Setting GCS Scoring Interval .................................................................................................................................................... 16 - 7

16.3.5 Reviewing GCS Trend Data ...................................................................................................................................................... 16 - 7

16.4 SepsisSight

TM ..................................................................................................................................................................................................................................................16 - 7

16.4.1 Accessing the SepsisSight Dialog .......................................................................................................................................... 16 - 8

16.4.2 Screening ........................................................................................................................................................................................ 16 - 8

16.4.3 Recommendations ...................................................................................................................................................................... 16 - 9

16.4.4 Reviewing SepsisSight Trend Data ........................................................................................................................................ 16 - 9

17 Calculation (only available when the N1 is used with the independent external display) .....................................17 - 1

17.1 Calculation Overview ................................................................................................................................................................................ 17 - 1

17.2 Calculation Safety Information ............................................................................................................................................................. 17 - 1

17.3 Drug Calculations ....................................................................................................................................................................................... 17 - 1

17.3.1 Performing Drug Calculations ................................................................................................................................................. 17 - 1

17.3.2 Checking the Titration Table ................................................................................................................................................... 17 - 2

17.3.3 Drug Calculation Formula ......................................................................................................................................................... 17 - 2

17.3.4 Titration Table Calculation Formula ...................................................................................................................................... 17 - 2

17.4 Hemodynamic Calculations ................................................................................................................................................................... 17 - 3

17.4.1 Performing Hemodynamic Calculations ............................................................................................................................. 17 - 3

17.4.2 Input Parameters for Hemodynamic Calculations ........................................................................................................... 17 - 3

17.4.3 Calculated Parameters and Formulas for Hemodynamic Calculations .................................................................... 17 - 3

17.5 Oxygenation Calculations ....................................................................................................................................................................... 17 - 4

BeneVision N1 Patient Monitor Operator’s Manual 9

17.5.1 Performing Oxygenation Calculations ................................................................................................................................ 17 - 4

17.5.2 Input Parameters for Oxygenation Calculations .............................................................................................................. 17 - 5

17.5.3 Calculated Parameters and Formulas for Oxygenation Calculations ....................................................................... 17 - 5

17.6 Ventilation Calculations .......................................................................................................................................................................... 17 - 6

17.6.1 Performing Ventilation Calculations .................................................................................................................................... 17 - 6

17.6.2 Input Parameters for Ventilation Calculations .................................................................................................................. 17 - 6

17.6.3 Calculated Parameters and Formulas for Ventilation Calculations ........................................................................... 17 - 6

17.7 Renal Calculations ..................................................................................................................................................................................... 17 - 7

17.7.1 Performing Renal Calculations ............................................................................................................................................... 17 - 7

17.7.2 Calculated Parameters and Formulas for Renal Calculations ...................................................................................... 17 - 7

17.7.3 Calculated Parameters and Formulas for Renal Calculations ...................................................................................... 17 - 8

18 Printing ..........................................................................................................................................................................18 - 1

18.1 Supported Printer ...................................................................................................................................................................................... 18 - 1

18.2 End Case Reports ....................................................................................................................................................................................... 18 - 1

18.2.1 Printing the End Case Report .................................................................................................................................................. 18 - 1

18.2.2 Setting a Report as An End Case Report ............................................................................................................................. 18 - 1

18.2.3 Configuring the End Case Reports ........................................................................................................................................ 18 - 1

18.2.4 Setting the End Case Report Period ..................................................................................................................................... 18 - 2

18.3 Manually Starting a Printing Task ........................................................................................................................................................ 18 - 2

18.3.1 Printing from the Screen ........................................................................................................................................................... 18 - 2

18.3.2 Printing Realtime Reports ........................................................................................................................................................ 18 - 2

18.3.3 Printing Most Common Reports ............................................................................................................................................ 18 - 2

18.4 Automatically Printing Reports ............................................................................................................................................................ 18 - 2

18.5 Stopping a Printing Task ......................................................................................................................................................................... 18 - 3

18.6 Configuring Reports ................................................................................................................................................................................. 18 - 3

18.6.1 Configuring ECG Reports .......................................................................................................................................................... 18 - 3

18.6.2 Configuring Realtime Reports ................................................................................................................................................ 18 - 4

18.6.3 Configuring Tabular Trends Reports .................................................................................................................................... 18 - 4

18.6.4 Configuring Graphic Trends Reports .................................................................................................................................... 18 - 5

18.7 Viewing Printer Status ............................................................................................................................................................................. 18 - 5

18.8 Printer Out of Paper .................................................................................................................................................................................. 18 - 5

18.9 List of Reports ............................................................................................................................................................................................. 18 - 5

19 Using the On-Screen Timers .........................................................................................................................................19 - 1

19.1 Displaying Timers ...................................................................................................................................................................................... 19 - 1

19.2 Controlling the Timer ............................................................................................................................................................................... 19 - 1

19.3 Setting the Timer ....................................................................................................................................................................................... 19 - 1

20 Managing Configurations .............................................................................................................................................20 - 1

20.1 Configuration Introduction .................................................................................................................................................................... 20 - 1

20.2 Changing the Department ..................................................................................................................................................................... 20 - 1

20.3 Setting Default Patient Category ......................................................................................................................................................... 20 - 1

20.4 Setting Default Configuration ............................................................................................................................................................... 20 - 1

20.5 Saving Current Settings ........................................................................................................................................................................... 20 - 2

20.6 Deleting a Configuration ........................................................................................................................................................................ 20 - 2

20.7 Transferring a Configuration ................................................................................................................................................................. 20 - 2

10 BeneVision N1 Patient Monitor Operator’s Manual

20.7.1 Exporting a Configuration ........................................................................................................................................................ 20 - 2

20.7.2 Importing a Configuration ....................................................................................................................................................... 20 - 3

20.7.3 Loading a Configuration ........................................................................................................................................................... 20 - 3

20.8 Printing Configurations ........................................................................................................................................................................... 20 - 3

20.9 Modifying Configuration Password .................................................................................................................................................... 20 - 3

21 Password-protected User Settings ..............................................................................................................................21 - 1

21.1 Setting the Device Location ................................................................................................................................................................... 21 - 1

21.1.1 Setting Monitor Information ................................................................................................................................................... 21 - 1

21.1.2 Setting Monitor Location .......................................................................................................................................................... 21 - 1

21.1.3 Enabling the Auto Obtain Bed Number Function ........................................................................................................... 21 - 1

21.2 Changing Patient Management Settings .......................................................................................................................................... 21 - 2

21.2.1 Selecting Displayed Patient Information ............................................................................................................................ 21 - 2

21.2.2 Auto Discharging a Patient after Monitor Power Off ...................................................................................................... 21 - 2

21.2.3 Clearing All Patient Data ........................................................................................................................................................... 21 - 2

21.2.4 Selecting Query Criteria for Searching Patients in ADT Server ................................................................................... 21 - 2

21.2.5 Setting Patient Location Options for the Discharge Screen ........................................................................................ 21 - 2

21.2.6 Hiding Patient Name .................................................................................................................................................................. 21 - 3

21.2.7 Select Whether a Prompt is Required When Auto Deleting Discharged Patients ............................................... 21 - 3

21.3 Changing the Alarm Settings ................................................................................................................................................................ 21 - 3

21.3.1 Setting Alarm Tone Properties ................................................................................................................................................ 21 - 3

21.3.2 Setting Alarm Pausing and Resetting Properties ............................................................................................................. 21 - 4

21.3.3 Defining the Pause Function ................................................................................................................................................... 21 - 4

21.3.4 Latching Physiological Alarms ................................................................................................................................................ 21 - 6

21.3.5 Changing Remote Alarm Settings ......................................................................................................................................... 21 - 6

21.3.6 Changing Alarm Priority Settings .......................................................................................................................................... 21 - 7

21.3.7 Changing Alarm Delay Settings ............................................................................................................................................. 21 - 9

21.3.8 Adjusting the Alarm Light Brightness .................................................................................................................................. 21 - 9

21.3.9 Changing Other Alarm Settings ...........................................................................................................................................21 - 10

21.4 Changing CAA Settings (only available when the N1 is used with the independent external display) ...................21 - 11

21.4.1 Enabling Inputing the Clinician ID .......................................................................................................................................21 - 11

21.4.2 Selecting the Default Scoring Tool ......................................................................................................................................21 - 11

21.4.3 Managing the Scoring Tools ..................................................................................................................................................21 - 11

21.4.4 Setting GCS Threshold for Each Consciousness Level ..................................................................................................21 - 11

21.5 Changing Module Settings ...................................................................................................................................................................21 - 12

21.5.1 Selecting the ECG Standard ...................................................................................................................................................21 - 12

21.5.2 Changing the QTc Formula ....................................................................................................................................................21 - 12

21.5.3 Setting the 12-Lead Order Switch .......................................................................................................................................21 - 12

21.5.4 Calibrating ECG ...........................................................................................................................................................................21 - 12

21.5.5 Manually Zeroing the CO

2

Module .....................................................................................................................................21 - 12

21.5.6 Hiding the Invalid Display after Zeroing the CO

2

Module ..........................................................................................21 - 13

21.5.7 Setting Parameter Measurement Timeout .......................................................................................................................21 - 13

21.5.8 Setting Flow Rate (For Sidestream CO

2

Module Without O

2

) ....................................................................................21 - 13

21.6 Hiding Undesired Review Tabs ...........................................................................................................................................................21 - 13

21.7 Setting the Printer ...................................................................................................................................................................................21 - 13

21.7.1 Setting the Printer Properties ................................................................................................................................................21 - 13

21.7.2 Setting the Report Type ..........................................................................................................................................................21 - 14

21.7.3 Setting the Report Layout ......................................................................................................................................................21 - 14

21.7.4 Setting Patient Information on 12-lead ECG Reports ...................................................................................................21 - 14

BeneVision N1 Patient Monitor Operator’s Manual 11

21.7.5 Configuring the Name of PDF Files ..................................................................................................................................... 21 - 15

21.7.6 Showing the Second Mark ..................................................................................................................................................... 21 - 15

21.7.7 Setting Parameter Unit ............................................................................................................................................................ 21 - 15

21.8 Setting the Time .......................................................................................................................................................................................21 - 15

21.8.1 Setting the Time Synchronization ....................................................................................................................................... 21 - 15

21.8.2 Enabling Auto Daylight Savings Time ............................................................................................................................... 21 - 16

21.9 Viewing Version Information ............................................................................................................................................................... 21 - 16

21.10 Checking Battery Information .......................................................................................................................................................... 21 - 16

21.11 Changing Scanner Settings ............................................................................................................................................................... 21 - 16

21.11.1 Establish the Relationship between Patient Demographics and 2D Barcode Fields (for the Mindray Custom

2D Barcode Reader) ................................................................................................................................................................. 21 - 17

21.11.2 Setting the Barcode Reader Information ....................................................................................................................... 21 - 17

21.11.3 Identifying the Barcode Reader (for the non-Mindray Custom 2D Barcode Reader) ..................................... 21 - 17

21.11.4 Selecting Patient Information Read by the Barcode Reader (for the Mindray Custom 2D Barcode Reader) 21

- 17

21.12 Configuring the Network ................................................................................................................................................................... 21 - 18

21.12.1 Network Safety Information ................................................................................................................................................ 21 - 18

21.12.2 Setting the Wireless Network ............................................................................................................................................. 21 - 18

21.12.3 Managing Certifications ....................................................................................................................................................... 21 - 18

21.12.4 Enabling Selecting a CMS .................................................................................................................................................... 21 - 19

21.12.5 Adding CMSs ............................................................................................................................................................................ 21 - 19

21.12.6 Setting Multicast Parameters .............................................................................................................................................. 21 - 19

21.12.7 Setting the Master Server Address ................................................................................................................................... 21 - 19

21.12.8 Setting the Network Service Quality Level .................................................................................................................... 21 - 19

21.12.9 Using the ADT Gateway ........................................................................................................................................................ 21 - 19

21.12.10 Sending Realtime Data, Waveforms and Alarms via HL7 Protocol .....................................................................21 - 20

21.12.11 Selecting Data Encryption Type ...................................................................................................................................... 21 - 20

21.12.12 Disabling the Broadcasting Patient Demographics Function ..............................................................................21 - 20

21.13 MLDAP ......................................................................................................................................................................................................21 - 20

21.13.1 Setting MLDAP ......................................................................................................................................................................... 21 - 21

21.13.2 Testing MLDAP Server Connection .................................................................................................................................. 21 - 21

21.13.3 Selecting Password for User Authentication ................................................................................................................ 21 - 21

21.13.4 Setting the Password Timeout Period ............................................................................................................................. 21 - 22

21.14 Setting the Dock ....................................................................................................................................................................................21 - 22

21.14.1 Setting the Work Mode ......................................................................................................................................................... 21 - 22

21.14.2 Setting the Net Setting Type .............................................................................................................................................. 21 - 22

21.14.3 Setting the Network of the Dock ....................................................................................................................................... 21 - 22

21.14.4 Setting the External Display ................................................................................................................................................ 21 - 23

21.15 Defining Other Functions ................................................................................................................................................................... 21 - 24

21.15.1 Setting Notch Filter Frequency .......................................................................................................................................... 21 - 24

21.15.2 Setting Mouse Sensitivity ..................................................................................................................................................... 21 - 24

21.15.3 Setting the SpO

2

Tone Mode .............................................................................................................................................. 21 - 24

21.15.4 Selecting the Language ........................................................................................................................................................ 21 - 25

21.15.5 Switching On or Off a Parameter ....................................................................................................................................... 21 - 25

21.15.6 Setting If Setting Parameter Switches is Protected .................................................................................................... 21 - 25

21.15.7 Setting If Parameter Switch is Influenced by Configuration ...................................................................................21 - 26

21.15.8 Setting the Outdoor Mode .................................................................................................................................................. 21 - 26

22 Battery ............................................................................................................................................................................22 - 1

12 BeneVision N1 Patient Monitor Operator’s Manual

22.1 Battery Introduction .................................................................................................................................................................................. 22 - 1

22.2 Battery Safety Information ..................................................................................................................................................................... 22 - 1

22.3 Installing the Battery ................................................................................................................................................................................ 22 - 1

22.4 Battery Indications ..................................................................................................................................................................................... 22 - 1

22.4.1 Battery LED ..................................................................................................................................................................................... 22 - 2

22.4.2 Battery symbols ............................................................................................................................................................................ 22 - 2

22.4.3 Battery Power Indicator ............................................................................................................................................................. 22 - 2

22.4.4 Battery-related Alarms ............................................................................................................................................................... 22 - 2

22.5 Charging the Battery ................................................................................................................................................................................ 22 - 3

22.6 Maintaining the Battery ........................................................................................................................................................................... 22 - 3

22.6.1 Conditioning the Battery .......................................................................................................................................................... 22 - 3

22.6.2 Checking Battery Performance ............................................................................................................................................... 22 - 3

22.7 Storing Batteries ......................................................................................................................................................................................... 22 - 4

22.8 Recycling Batteries .................................................................................................................................................................................... 22 - 4

23 Care and Cleaning .........................................................................................................................................................23 - 1

23.1 Care and Cleaning Introduction ........................................................................................................................................................... 23 - 1

23.2 Care and Cleaning Safety Information ............................................................................................................................................... 23 - 1

23.3 Cleaning and Disinfecting the Equipment and Mounting Kits ................................................................................................. 23 - 2

23.3.1 Approved Cleaning and Disinfecting Agents ................................................................................................................... 23 - 2

23.3.2 Cleaning the Equipment and Mounting Kits ..................................................................................................................... 23 - 3

23.3.3 Disinfecting the Equipment and Mounting Kits ............................................................................................................... 23 - 3

23.4 Cleaning and Disinfecting the Accessories ...................................................................................................................................... 23 - 3

23.4.1 Approved Accessories Cleaning and Disinfecting Agents ............................................................................................ 23 - 4

23.4.2 Cleaning the Accessories .......................................................................................................................................................... 23 - 5

23.4.3 Disinfecting the Accessories .................................................................................................................................................... 23 - 5

23.5 Sterilization .................................................................................................................................................................................................. 23 - 5

24 Maintenance ..................................................................................................................................................................24 - 1

24.1 Maintenance Introduction ...................................................................................................................................................................... 24 - 1

24.2 Maintenance Safety Information .......................................................................................................................................................... 24 - 1

24.3 Maintenance and Testing Schedule .................................................................................................................................................... 24 - 2

24.4 Checking System Software Version ..................................................................................................................................................... 24 - 2

24.5 Testing Methods and Procedures ........................................................................................................................................................ 24 - 2

24.5.1 Performing Visual Inspection .................................................................................................................................................. 24 - 2

24.5.2 Performing Power-on Test ....................................................................................................................................................... 24 - 3

24.5.3 Testing the Network Printer .................................................................................................................................................... 24 - 3

24.5.4 Checking the Battery .................................................................................................................................................................. 24 - 3

24.6 NIBP Maintenance ..................................................................................................................................................................................... 24 - 3

24.6.1 NIBP Leakage Test ....................................................................................................................................................................... 24 - 3

24.6.2 NIBP Accuracy Test ...................................................................................................................................................................... 24 - 3

24.7 Disposing of the Monitor ........................................................................................................................................................................ 24 - 3

25 Accessories .....................................................................................................................................................................25 - 1

25.1 ECG Accessories .......................................................................................................................................................................................... 25 - 1

25.1.1 ECG Electrodes Available for Purchase ............................................................................................................................... 25 - 1

25.1.2 ECG Electrodes Also Compatible ........................................................................................................................................... 25 - 1

BeneVision N1 Patient Monitor Operator’s Manual 13

25.1.3 12-Pin Trunk Cables Available for Purchase ...................................................................................................................... 25 - 2

25.1.4 12-Pin Trunk Cables Also Compatible .................................................................................................................................. 25 - 2

25.1.5 3-lead ECG Leadwires Available for Purchase ................................................................................................................... 25 - 2

25.1.6 3-lead ECG Leadwires Also Compatible .............................................................................................................................. 25 - 3

25.1.7 5-lead ECG Leadwires Available for Purchase ................................................................................................................... 25 - 3

25.1.8 5-lead ECG Leadwires Also Compatible .............................................................................................................................. 25 - 3

25.1.9 6-lead ECG Leadwires Available for Purchase ................................................................................................................... 25 - 4

25.1.10 12-lead ECG Chest Leadwires Available for Purchase .................................................................................................. 25 - 4

25.1.11 12-lead ECG Leadwires Also Compatible ......................................................................................................................... 25 - 4

25.2 SpO

2

Accessories ....................................................................................................................................................................................... 25 - 4

25.2.1 Extension Cables and Adapter Cables Available for Purchase .................................................................................... 25 - 4

25.2.2 Extension Cables and Adapter Cables Also Compatible ............................................................................................... 25 - 4

25.2.3 Masimo SpO

2

RD Set Sensors Available for Purchase .................................................................................................... 25 - 5

25.2.4 Masimo SpO

2

LNCS Sensors Also Compatible .................................................................................................................. 25 - 5

25.2.5 Nellcor SpO

2

Sensors Also Compatible ............................................................................................................................... 25 - 5

25.3 Temp Accessories ..................................................................................................................................................................................... 25 - 6

25.3.1 Temp Cable Available for Purchase ...................................................................................................................................... 25 - 6

25.3.2 Temp Cable Also Compatible ................................................................................................................................................. 25 - 6

25.3.3 Temp Probes Available for Purchase .................................................................................................................................... 25 - 6

25.3.4 Temp Probes Also Compatible ............................................................................................................................................... 25 - 6

25.4 NIBP Accessories ........................................................................................................................................................................................ 25 - 7

25.4.1 NIBP Hoses Available for Purchase ....................................................................................................................................... 25 - 7

25.4.2 Cuffs Available for Purchase .................................................................................................................................................... 25 - 7

25.5 IBP Accessories ........................................................................................................................................................................................... 25 - 8

25.5.1 IBP Accessories Available for Purchase ................................................................................................................................ 25 - 8

25.5.2 ICP Accessories Available for Purchase ............................................................................................................................... 25 - 8

25.6 CO

2

Accessories .......................................................................................................................................................................................... 25 - 8

25.6.1 Sidestream CO

2

Accessories Available for Purchase ...................................................................................................... 25 - 8

25.6.2 Microstream CO

2

Accessories Intended for Sale .............................................................................................................. 25 - 9

25.6.3 Microstream CO

2

Accessories Also Compatible ............................................................................................................... 25 - 9

25.7 External Modules ....................................................................................................................................................................................... 25 - 9

25.8 Mount and Mounting Accessories ...................................................................................................................................................... 25 - 9

25.9 Miscellaneous Accessories ................................................................................................................................................................... 25 - 10

A Product Specifications ..................................................................................................................................................... A - 1

A.1 Monitor Safety Specifications ................................................................................................................................................................... A - 1

A.2 Physical Specifications ................................................................................................................................................................................. A - 1

A.3 Environmental Specifications ................................................................................................................................................................... A - 1

A.4 Power Supply Specifications ..................................................................................................................................................................... A - 2

A.4.1 External Power Supply Specifications ...................................................................................................................................... A - 2

A.4.2 Battery Specifications .................................................................................................................................................................... A - 3

A.5 Display Specifications .................................................................................................................................................................................. A - 3

A.6 Touchscreen Specifications ....................................................................................................................................................................... A - 4

A.7 LEDs .................................................................................................................................................................................................................... A - 4

A.7.1 Main Unit ............................................................................................................................................................................................ A - 4

A.7.2 Dock ..................................................................................................................................................................................................... A - 4

A.7.3 Transport Dock ................................................................................................................................................................................. A - 4

14 BeneVision N1 Patient Monitor Operator’s Manual

A.7.4 AC Adapter ......................................................................................................................................................................................... A - 4

A.8 Audio Indicator ............................................................................................................................................................................................... A - 4

A.9 Monitor Interface Specifications .............................................................................................................................................................. A - 4

A.9.1 Interface Specifications of the Main Unit ................................................................................................................................ A - 4

A.9.2 Interface Specifications of the Modular Rack ........................................................................................................................ A - 5

A.9.3 Interface Specifications of the Dock ......................................................................................................................................... A - 5

A.10 Signal Outputs Specifications ................................................................................................................................................................. A - 5

A.11 Data Storage .................................................................................................................................................................................................. A - 6

A.12 Out-Of-Hospital Transport - Standards Compliance ...................................................................................................................... A - 6

A.13 Wi-Fi Specifications ..................................................................................................................................................................................... A - 7

A.13.1 Wi-Fi Technical Specifications (MSD45N) ............................................................................................................................. A - 7

A.13.2 Wi-Fi Performance Specifications ............................................................................................................................................ A - 7

A.14 Measurement Specifications ................................................................................................................................................................... A - 9

A.14.1 ECG Specifications ........................................................................................................................................................................ A - 9

A.14.2 Resp Specifications .....................................................................................................................................................................A - 11

A.14.3 SpO

2

Specifications ....................................................................................................................................................................A - 12

A.14.4 PR Specifications ..........................................................................................................................................................................A - 13

A.14.5 Temp Specifications ...................................................................................................................................................................A - 14

A.14.6 NIBP Specifications .....................................................................................................................................................................A - 14

A.14.7 IBP Specifications ........................................................................................................................................................................A - 16

A.14.8 CO

2

Specifications .......................................................................................................................................................................A - 17

B EMC and Radio Regulatory Compliance ..........................................................................................................................B - 1

B.1 EMC ...................................................................................................................................................................................................................... B - 1

B.2 Radio Regulatory Compliance ................................................................................................................................................................... B - 4

C Default Settings .................................................................................................................................................................C - 1

C.1 ECG, Arrhythmia, ST and QT Default Settings ...................................................................................................................................... C - 1

C.1.1 ECG Default Settings ....................................................................................................................................................................... C - 1

C.1.2 Arrhythmia Default Settings ........................................................................................................................................................ C - 2

C.1.3 ST Default Settings .......................................................................................................................................................................... C - 3

C.1.4 QT Default Settings ......................................................................................................................................................................... C - 4

C.1.5 Glasgow 12-lead ECG Algorithm Default Settings ............................................................................................................... C - 4

C.2 Respiration Default Settings ...................................................................................................................................................................... C - 4

C.3 SpO

2

Default Settings ................................................................................................................................................................................... C - 5

C.4 Temperature Default Settings ................................................................................................................................................................... C - 6

C.5 NIBP Default Settings .................................................................................................................................................................................... C - 6

C.6 IBP Default Settings ....................................................................................................................................................................................... C - 8

C.7 CO

2

Default Settings ...................................................................................................................................................................................C - 11

C.7.1 General Settings .............................................................................................................................................................................C - 11

C.7.2 Sidestream CO2 Default Settings .............................................................................................................................................C - 12

C.7.3 Microstream CO2 Default Settings ..........................................................................................................................................C - 12

C.8 Alarm Default Settings ...............................................................................................................................................................................C - 13

C.9 Display Default Settings ............................................................................................................................................................................C - 13

D Alarm Messages ............................................................................................................................................................... D - 1

D.1 Physiological Alarm Messages ..................................................................................................................................................................D - 1

BeneVision N1 Patient Monitor Operator’s Manual 15

D.1.1 General Physiological Alarm Messages ................................................................................................................................... D - 1

D.1.2 Arrhythmia Alarm Messages ....................................................................................................................................................... D - 1

D.1.3 Resp Physiological Alarm Messages ......................................................................................................................................... D - 2

D.1.4 SpO

2

Physiological Alarm Messages ........................................................................................................................................ D - 2

D.1.5 PR

Physiological Alarm Messages ............................................................................................................................................. D - 2

D.1.6 NIBP Physiological Alarm Messages ......................................................................................................................................... D - 2

D.1.7 IBP Physiological Alarm Messages ............................................................................................................................................ D - 2

D.1.8 CO

2

Physiological Alarm Messages .......................................................................................................................................... D - 3

D.2 Technical Alarm Messages ......................................................................................................................................................................... D - 3

D.2.1 General Technical Alarm Messages .......................................................................................................................................... D - 3

D.2.2 ECG Technical Alarm Messages ................................................................................................................................................. D - 3

D.2.3 Resp Technical Alarm Messages ................................................................................................................................................ D - 4

D.2.4 SpO

2

Technical Alarm Messages ................................................................................................................................................ D - 4

D.2.5 Temp Technical Alarm Messages .............................................................................................................................................. D - 5

D.2.6 NIBP Technical Alarm Messages ................................................................................................................................................ D - 5

D.2.7 IBP Technical Alarm Messages ................................................................................................................................................... D - 5

D.2.8 CO

2

Technical Alarm Messages .................................................................................................................................................. D - 6

D.2.9 Power Supply

Technical Alarm Messages .............................................................................................................................. D - 7

D.2.10 Printer Technical Alarm Messages .......................................................................................................................................... D - 8

D.2.11 Technical Alarm Messages Related to Networked Monitoring .................................................................................... D - 8

D.2.12 Other System Technical Alarm Messages ............................................................................................................................ D - 9

E SpO

2

Sensor Accuracy ....................................................................................................................................................... E - 1

E.1 The Accuracy of Masimo SpO

2

Sensors ................................................................................................................................................... E - 1

E.2 The Accuracy of Nellcor SpO

2

Sensors .................................................................................................................................................... E - 3

F Units, Symbols and Abbreviations ................................................................................................................................... F - 1

F.1 Units ..................................................................................................................................................................................................................... F - 1

F.2 Symbols .............................................................................................................................................................................................................. F - 2

F.3 Abbreviations ................................................................................................................................................................................................... F - 3

16 BeneVision N1 Patient Monitor Operator’s Manual

1

Safety

1.1

1.1.1

Safety Information

WARNING

Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury.

CAUTION

Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.

NOTE

Provides application tips or other useful information that does not involve patient or user risk.

Warnings

WARNING

Patient with a pacemaker – on ventricular paced patients, episodes of Ventricular Tachycardia may not always be detected. Do not rely entirely upon the system’s automated arrhythmia detection algorithm. Keep pacemaker patients under close surveillance.

This equipment is used for a single patient at a time.

To avoid explosion hazards, do not use the equipment in the presence of oxygen-rich atmospheres, flammable anesthetics, or other flammable agents.

Do not touch the equipment’s metal parts or connectors when in contact with the patient; otherwise patient injury may result.

Never mix patient electrode types or brands. Dissimilar metals or other incompatibilities may cause considerable baseline drift and may increase trace recovery time after defibrillation.

To reduce the hazard of burns during high-frequency surgical procedure, ensure that the monitor’s cables and transducers never come into contact with the electro-surgery unit (ESU).

The neutral electrode of the electro-surgery unit (ESU) shall properly contact the patient. Otherwise, burns may result.

MR unsafe: the N1 monitor is not intended to be used within the Magnetic Resonance (MR) environment.

Before connecting the equipment to the mains power, ensure that the voltage and frequency ratings of the power line are the same as those indicated on the equipment’s label or in this manual.

Before putting the system into operation, the operator must verify that the equipment, connecting cables, and accessories are in correct working order and operating condition.

To avoid risk of electric shock, the equipment must only be connected to mains power with protective earth, or operated on battery power.

Do not touch the patient and live parts simultaneously. Otherwise patient injury may result.

Do not touch the patient or metal parts in contact with the patient during defibrillation. Otherwise serious injury or death could result.

Do not open the equipment housings. All servicing and future upgrades must be carried out by trained and authorized personnel.

BeneVision N1 Patient Monitor Operator’s Manual 1 - 1

Do not rely exclusively on the audible alarm system for patient monitoring. Turning the alarm volume to a low level or off may result in a hazard to the patient. Always keep the patient under close surveillance.

Alarm settings should be customized according to patient situations.

Do not place the equipment or accessories in any position that might cause it to fall on the patient.

Do not start or operate the equipment unless the setup was verified to be correct.

To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and secure excess cabling to reduce risk of entanglement by patients or personnel.

The physiological data and alarm messages displayed on the equipment are for reference only and cannot be directly used for diagnostic interpretation. The equipment should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptom. If any measurement seems questionable, first check the patient’s vital signs by alternate means and then check the equipment for proper functioning.

1.1.2

Cautions

CAUTION

Use only parts and accessories specified in this manual.

Disposable accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy.

Ensure that the equipment is supplied with continuous electric power during operation from the mains power or batteries. Sudden power failure may cause data loss.

When no battery is installed, ensure that the monitor is supplied with continuous electric power during operation. Sudden power failure may lead to data loss.

Store and use the equipment in specified environmental condition. The monitor and accessories may not meet the performance specification due to aging, stored or used outside the specified temperature and humidity range.

Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phones, X-ray equipment, and MRI devices are possible sources of interference as they may emit higher levels of electromagnetic radiation.

Always install or carry the equipment properly to avoid damage caused by drops, impacts, strong vibrations or other mechanical forces.

Dry the equipment immediately in case of rain or water spray.

Some settings are password protected and can only be changed by authorized personnel. Contact your department manager or biomedical engineering department for the passwords used at your facility.

Do not loop the patient cabling into a tight coil or wrap around the device, as this can damage the patient cabling.

Dispose of the package material as per the applicable waste control regulations. Keep it out of children’s reach.

At the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the equipment, please contact Mindray.

1.1.3

Notes

NOTE

The equipment software copyright is solely owned by Mindray. No organization or individual shall resort to modifying, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission.

Put the equipment in a location where it can be easily viewed and operated.

1 - 2 BeneVision N1 Patient Monitor Operator’s Manual

1.2

The equipment uses a mains plug as isolation means to the mains power. Do not locate the equipment in a place difficult to access the mains plug.

During normal use, the operator is expected to face the front of the equipment.

Remove the battery before shipping the monitor or if it will not be used for an extended period of time.

Remove the battery before transporting the equipment or if the equipment will not be used for a long time.

The software was developed in compliance with IEC62304, to minimize the possibility of hazards arising from software errors.

This manual is based on the maximum configuration and therefore some contents may not apply to the product. If you have any question, please contact Mindray.

Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.

Keep this manual in the vicinity of the equipment so that it can be referenced when needed.

Equipment Symbols

Symbol Description

General warning sign

Symbol Description

Refer to instruction manual/booklet

Serial number

Date of manufacture

USB connector

IP44: protected against ingress of foreign objects no less than 1.0 mm, and against access to hazardous parts with wire; protect against harmful effects of splashing water

Battery indicator

Direct current

Equipotentiality

Catalogue number

Manufacturer

Protected against vertically falling water drops per IEC 60529

IP22: protected against ingress of foreign objects no less than 12.5 mm and against access to hazardous parts with finger; protected against harmful effects of vertically falling water drops with the device tilted at any angle up to 15°

Computer network

Lock; tighten

Alternating current

Defibrillation-proof type CF applied part Defibrillation-proof type BF applied part

BeneVision N1 Patient Monitor Operator’s Manual 1 - 3

1 - 4

Symbol Description

Direction and angle off rotation

Input/output

Locking

NIBP start/stop

Start

Stand-by

Gas outlet

Video output

Dispose of in accordance to local requirements

Pushing prohibited (wheels locked, no pushing)

Symbol Description

Polarity of d.c. power connector

IBP zero key

Unlocking

Calibration

Stop

Menu

Gas inlet

Non-ionizing electromagnetic radiation

Plastic identification symbol

Conforms to ANSI Std. ES60601-1, IEC Std.

60601-1-8, IEC Std. 60601-2-25, IEC Std.

60601-2-26, IEC Std. 60601-2-27, IEC Std.

80601-2-30, IEC Std. 60601-2-34, IEC Std.

60601-2-49, ISO Std. 0601-2-55, ISO Std.

80601-2-56, and ISO Std. 80601-2-61

Certified to CAN/CSA Std. C22.2 No. 60601-1,

No. 60601-1-6, No. 60601-1-8, No. 60601-2-25,

No. 60601-2-26, No. 60601-2-27, No. 80601-2-

30, No. 60601-2-34, No. 60601-2-49, No.

80601-2-55, No. 80601-2-56, and No.

80601-2-61

BeneVision N1 Patient Monitor Operator’s Manual

2

Equipment Introduction

2.1

2.2

2.3

Indications for Use

The BeneVision N1 Patient Monitor is intended for monitoring, displaying, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable,

Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature

(Temp), Pulse Oxygen Saturation (SpO

2

), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood

Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO

2

) and Oxygen (O

2

). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

■ The arrhythmia detection and PAWP is intended for adult and pediatric patients only

The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

NOTE

This manual is based on the maximum configuration and therefore some contents may not apply to the product. If you have any question, please contact Mindray.

Equipment Features

The monitor is intended to be used in a hospital environment including, but not limited to, ICU, CCU, PICU,

Neonatology, RICU, emergency room, operating room, postoperative observation ward, etc.

The monitor can be used in two ways:

As a stand-alone patient monitor, or

As a multi-parameter module (MPM) for the Mindray BeneVision N22, BeneVision N19, BeneVision N17,

BeneVision N15, or BeneVision N12 patient monitor, hereafter referred to as “the host monitor”.

In this manual, the N1 is generally referred to as “the monitor” except in the situation describing its use with a host monitor, where it is referred to as “the N1” to distinguish it from the host monitor.

Applied Parts

The applied parts of the monitor are:

ECG electrode and leadwire

SpO

2

sensor

Temp probe

NIBP cuff

IBP transducer

CO

2

sampling line/nasal sampling cannula, water trap, and mask

BeneVision N1 Patient Monitor Operator’s Manual 2 - 1

2.4

2.4.1

Main Unit

Front View

(1) (2)

BeneVision N1

(3)

(4)

(5)

(1)

(2)

(3)

(5)

Alarm lamp:

When a physiological alarm or technical alarm occurs, this lamp lights and flashes corresponding with the alarm priority:

• High priority alarms: the lamp quickly flashes red.

• Medium priority alarms: the lamp slowly flashes yellow.

• Low priority alarms: the lamp lights in cyan without flashing.

Ambient light sensor

When screen brightness is set to auto, the system automatically adjusts screen brightens according to the strength of ambient light.

Display

• Yellow: the battery is being charged.

• Green: the battery is fully charged.

• Flashing green: the monitor runs on battery power.

• Flashing yellow: the battery is malfunctioning.

• Off: no battery is installed, or the monitor is powered off and no external power is connected.

External power supply indicator:

• On: when external power supply is connected.

• Off: when external power supply is not connected.

2 - 2 BeneVision N1 Patient Monitor Operator’s Manual

2.4.2

Left View

(5)

(4)

(1)

(2)

(3) (3)

(1)

(2)

(3)

(4)

(5)

Communication interface: used for communication between the

N1 and host monitor (BeneVision N series monitor).

Infrared filter: used for communication between the N1 and N series monitor if the communication interface does not work.

Contact: used for receiving power supply from the host monitor

(BeneVision N series monitor).

Multi-pin connector: connects the N1 to the Modular Rack or Dock.

External DC power input connector: connects the N1 to the AC adapter

NOTE

To ensure good contact, clean the contacts regularly, as dust and dirt may collect on them. When cleaning the contacts, wipe them with cotton, dampened with alcohol. Using forceps is recommended.

In the case of water spray, dry the Multi-pin connector of the N1 before connecting the N1 to the

Modular Rack or Dock.

BeneVision N1 Patient Monitor Operator’s Manual 2 - 3

2.4.3

Right View

(1) (2) (3)

(9)

(8)

(4)

(5)

(6)

2.4.4

(7)

(1)

(4)

(7)

(9)

Power switch (2) Sample line connector for sidestream CO

2

ECG cable connector (5) SpO

2

sensor connector

Multifunctional connector: outputs analog ECG, IBP and defib synchronization signals.

Temperature probe connector

(3) Gas outlet

(6)

(8)

NIBP cuff connector

IBP cable connector

Bottom View

(1)

(2)

(1)

2.5

2 - 4

(1)

(2)

Clip: fastens the N1 when N1 is in use with the host monitor, Dock or Modular Rack.

Latch: locks the N1 when the N1 is in use with the host monitor, Dock or Modular Rack. Pressing here releases the N1 so that the N1 can be removed from the host monitor, Dock or Modular Rack.

Modular Rack

The Modular Rack is used to connect an N1 and an external parameter module as well as providing bed rail mounting capability. It can also be connected to the Dock.

BeneVision N1 Patient Monitor Operator’s Manual

2.5.1

Left View

(1)

(2)

2.5.2

(1)

(2)

Release button: pressing this button releases the Modular Rack from the Dock.

Multi-pin connector: connects the Modular Rack and Dock.

Right View

(1)

(2)

(3)

(4)

(1)

(2)

(3)

(4)

Multi-pin connector: connects the Modular Rack and N1.

Pogo pin: used for communication between the Modular Rack and external parameter module.

Infrared filter: used for communication between the Modular Rack and external parameter module.

Contact: power input connector of the external parameter module.

BeneVision N1 Patient Monitor Operator’s Manual 2 - 5

2.6

2.6.1

Dock

The Dock is used to connect the N1 or Modular Rack to provide power, charge the installed battery, and support connection to an external display, USB drive, network cables, and the BeneVision N series patient monitors.

Left View

(1)

(2)

2.6.2

(1)

(2)

Symbol: indicates the direction and angle that Dock can rotate when Dock is fixed onto a transverse or a vertical rod.

Pole mount seat: used to fix the pole mount to the Dock and then to a transverse or a vertical rod.

Right View

(1)

(3)

2 - 6

(2)

(1)

(2)

(3)

Multi-pin connector: power input and communication connector of the N1.

Connection status indicator: it is on when the N1 is properly connected to the Dock.

External power supply indicator: it is on when the external AC power supply is connected.

BeneVision N1 Patient Monitor Operator’s Manual

2.6.3

Rear View

(1) (2) (3) (4) (5) (6)

2.7

(1)

(2)

(3)

(4)

(5)

(6)

AC Power input connector

Equipotential grounding terminal: when using the monitor together with other devices, connect their equipotential grounding terminals together to eliminate the potential difference between them.

VGA connector: connects the external display

Host monitor connector: connects the N1 to the host monitor through a cable.

USB connector: connects USB devices.

Network connector: a standard RJ45 connector which connects the monitor to the CMS. It can also be used to transfer data..

External Parameter Modules

The monitor can connect the following external parameter modules through the Modular Rack.

Sidestream CO

2

module

BeneVision N1 Patient Monitor Operator’s Manual

Microstream CO

2

module IBP module

2 - 7

2.8

2.8.1

Installation

Installing the N1 or External Parameter Module into the Modular Rack

Install the N1, and an external parameter module if needed, to the Modular Rack as indicated below:

Firmly push the N1 or the external module until an audible click is heard indicating that the clip (refer to

2.4.4 Bottom View

) engaged the Modular Rack. To ensure that the N1 or the external module is properly connected, try to pull the N1 or the external module outward. The N1 or the external module has properly engaged the Modular Rack if it cannot be pulled out.

NOTE

To prevent the N1 or the external module from falling out of the Modular Rack, after inserting the N1 or the external module into the Modular Rack, always check that the N1 or the external module properly engaged the Modular Rack.

When the external module is properly installed, it should be further fasten to the Modular Rack with the lock at the bottom of the module to ensure the engagement.

2.8.2

Removing the N1 or External Parameter Module from the Modular Rack

To remove the N1 or external parameter module, follow this procedure:

1.

Press and hold the latch at the bottom of the N1 or parameter module. If the external module is locked to the Modular Rack, unlock it first.

2.

Pull the N1 or parameter module out as indicated.

1

2

1

2

BeneVision N1 Patient Monitor Operator’s Manual 2 - 8

2.8.3

Installing the Modular Rack to the Dock

The Modular Rack can be installed to the Dock as indicated below:

2.8.4

A click is heard when the Modular Rack is pushed into place.

Removing the Modular Rack from the Dock

To remove the Modular Rack from the Dock, follow this procedure:

.

1.

Press and hold down the release button at the top of the Modular Rack.

2.

Pull the Modular Rack out as indicated.

1

2

CAUTION

To prevent the Dock from falling off, do not press the release button while transporting the N1 with the Modular Rack and Dock.

2.8.5

Installing the N1 to the Dock

The N1can also be installed directly to the Dock as shown below:

BeneVision N1 Patient Monitor Operator’s Manual 2 - 9

2.8.6

Firmly push the N1 until an audible click is heard indicating that the clip (refer to 2.4.4 Bottom View ) engaged the

Dock. To ensure that the N1 is properly connected, try to pull the N1 outward. The N1 has properly engaged the

Dock if it cannot be pulled out.

Removing the N1 from the Dock

To remove the N1 from the Dock, follow this procedure:

1.

Press and hold the latch at the bottom of the N1.

2.

Pull the N1 out as indicated.

2

1

2.9

2.9.1

N1 in Use with a Host Monitor

When the N1 is connected to the BeneVision N series monitor, the N1 works as the parameter module while

BeneVision N series monitor works as the host monitor. For more information, see section 3.7.2 Module Mode .

The N1 can be connected to the host monitor through the following parts:

The module rack of the host monitor

The Satellite Module Rack (SMR)

The Dock

Connecting the N1 to the Host Monitor through the Module Rack

To connect the N1 to the module rack of the host monitor, follow this procedure:

1.

Insert the N1 to the host monitor’s module rack. Firmly push the N1 until an audible click is heard indicating that the clip (refer to

2.4.4 Bottom View ) engaged the module rack.

2 - 10 BeneVision N1 Patient Monitor Operator’s Manual

2.

To ensure that N1 is properly connected, try to pull N1 outward. The N1 has properly engaged the module rack if it cannot be pulled out.

To remove the N1 from the module rack of the host monitor, lift the latch (refer to 2.4.4 Bottom View ) at the

bottom of the N1 and pull the N1 out.

CAUTION

To prevent the N1 from falling out, after inserting the N1 into the module rack, always check that the

N1 properly engaged the module rack.

To prevent the N1 from falling, catch it with another hand while pulling it out from the module rack.

NOTE

There is no module rack for the BeneVision N22 or BeneVision N19 monitors. The N1 can be connected to the BeneVision N22 or BeneVision N19 monitor through the SMR or Dock.

2.9.2

Connecting the N1 to the Host Monitor through the Satellite Module Rack

(SMR)

To connect the N1 to the host monitor through the SMR, follow this procedure:

1.

Connect the SMR to the host monitor.

2.

Insert the N1 to the SMR. Firmly push the N1 until an audible click is heard indicating that the clip (refer to

2.4.4 Bottom View

) engaged the SMR.

3.

To ensure that the N1 is properly connected, try to pull the N1 outward. The N1 has properly engaged the module rack if it cannot be pulled out.

2.9.3

To remove the N1 from the SMR, lift the latch (refer to

2.4.4 Bottom View

) at the bottom of the N1 and pull the N1 out.

CAUTION

To prevent N1 from falling out, after inserting the N1 into the SMR, always check that the N1 properly engaged the SMR.

To prevent the N1 from falling, catch it with another hand while pulling it out from the SMR.

Connecting the N1 to the Host Monitor through the Dock

To connect the N1 to the host monitor through the Dock, follow this procedure:

1.

Connect the N1 to the Dock.

2.

Connect the host monitor connector of the Dock with the SMR connector of the host monitor using the dock data cable.

BeneVision N1 Patient Monitor Operator’s Manual 2 - 11

2.10

N1 in Use with the Transport Dock

The N1can be used with the Transport Dock to transport a patient via ambulance, airplane fuselage or helicopter fuselage. For the installation instructions of the N1 and Transport Dock, refer to the Transport Dock Indication for

Use (PN: H-046-011365-00) .

(4)

(3)

(2)

(1)

(1) DC power input

(3) Upper cover

(2) Power supply indicator

(4) Slide block for unlocking the N1

WARNING

The monitor must only be connected to mains power with protective earth, and the connection should be performed by qualified service personnel.

Ensure that the external power system has secure protective earth when the monitor is used together with the Transport Dock.

Verify that the connection of protective earth and the external power system is securely connected when installing the Transport Dock.

2.11

Input Devices

The monitor allows data entry through touchscreen, keyboard, mouse, and barcode reader.

2.12

Printing Devices

Use only Mindray specified printers to output patient information and data.

2 - 12 BeneVision N1 Patient Monitor Operator’s Manual

3

Getting Started

3.1

Equipment Preparation Safety Information

WARNING

Use only installation accessories specified by Mindray.

Connect only approved devices to this equipment. Devices connected to the equipment must meet the requirements of the applicable IEC standards (e.g. IEC 60950 safety standards for information technology equipment and IEC 60601-1 safety standards for medical electrical equipment). The system configuration must meet the requirements of the IEC 60601-1 medical electrical systems standard. Any personnel who connect devices to the equipment’s signal input/output port are responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601-1. If you have any questions, please contact Mindray.

The monitor and parameter monitoring accessories are suitable for use within the patient environment. For other equipment and accessories connected to the monitor, consult corresponding manufacturers for the suitability within the patient environment.

If it is not evident from the equipment specifications whether a particular combination with other devices is hazardous, for example, due to summation of leakage currents, please consult the manufacturer or an expert in the field. A determination must be made that the proposed combination will not negatively affect the devices themselves or the patient's safety.

CAUTION

The equipment should be installed by Mindray authorized personnel.

When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach.

Before use, verify whether the packages are intact, especially the packages of single use accessories.

In case of any damage, do not apply it to the patient.

Make sure that the equipment operating environment meets the specific requirements. Otherwise unexpected consequences, e.g. damage to the equipment, could result.

Avoid rough handling during transport.

NOTE

This manual is based on the maximum configuration and therefore some contents may not apply to the product. If you have any question, please contact Mindray.

Put the equipment in a location where it can be easily viewed and operated.

Keep this manual in the vicinity of the equipment so that it can be referenced when needed.

Save the packing case and packaging material as they can be used if the equipment must be reshipped.

Many settings in the patient monitor are password protected. It is recommended to change the default passwords and keep the passwords safe. Passwords should only be changed by authorized personnel. Contact the department manager or biomedical engineering department for the passwords used at the facility.

BeneVision N1 Patient Monitor Operator’s Manual 3 - 1

3.2

3.2.1

3.2.2

Monitor Installation

Unpacking and Checking

Before unpacking, examine the packaging carefully for signs of damage. If any damage is detected, contact the carrier, distributor, or Mindray.

If the packing case is intact, open the package and remove the equipment and accessories carefully. Check all materials against the packing list and check for any mechanical damage. Contact Mindray in case of any problems.

NOTE

If the N1 purchased contains the internal CO

2

module, connect the CO

2

adapter to the CO

2

receptacle soon after unpacking the monitor to avoid losing the CO

2

adapter.

Environmental Requirements

The operating environment of the equipment must meet the requirements specified in this manual.

The environment where the equipment is used shall be reasonably free from noises, vibration, dust, corrosive, flammable and explosive substances. Moreover, to maintain good ventilation, the equipment shall be at least 2 inches (5cm) away from around the cabinet.

When the equipment is moved from one place to another, condensation may occur as a result of temperature or humidity difference. In this case, never start the system before the condensation evaporates.

CAUTION

Make sure that the equipment operating environment meets the specific requirements. Otherwise unexpected consequences, e.g. damage to the equipment, could result.

3.3

Setting Up the Equipment

Observance of this manual is a prerequisite for proper product performance and correct operation. It ensures patient and operator safety.

3.3.1

Connecting the AC Mains

The monitor can be powered by AC power supply when it is connected to the AC adapter or Dock. Before connecting the equipment to the AC mains, check that the voltage and frequency ratings of the power line are the same as those indicated on the AC adapter or Dock.

3.3.1.1

Connecting the AC Mains through the AC Adapter

To connect the N1 to the AC power source through the AC adapter, follow this procedure:

1.

Connect the N1 to the AC adapter.

2.

Connect the female end of the power cord to the AC adapter, and the male end of the power cord to a wall

AC outlet.

3.

Check that the external power supply indicator is on.

The external power supply indicator lies in the lower right corner of the display. When the AC mains is not connected, the external power supply indicator is off. When AC mains is connected, the external power supply indicator is illuminated in green.

3.3.1.2

Connecting the AC Mains through the Dock

To connect the N1 to the AC power source through the Dock, follow this procedure:

1.

Connect the N1 to the Dock.

2.

Connect the female end of the power cord to the AC power input of the Dock, and the male end of the power cord to a wall AC outlet.

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3.3.2

3.3.3

3.4

3.

Check that the external power supply indicator of the N1 and Dock are on.

WARNING

Operate the equipment on battery power if the integrity of the protective earth conductor or the protective earthing system in the installation is in doubt.

CAUTION

Always use the accompanying power cord delivered with the monitor.

Always use the AC adapter specified by Mindray.

Before connecting the equipment to the AC mains, check that the voltage and frequency ratings of the power line are the same as those indicated on the AC adapter and Dock.

NOTE

Use the cable retainer to secure the power cord to prevent it from falling off.

Use AC power source when the N1 is in use with the Dock.

Connecting the Input Devices

Connect the mouse, keyboard, and/or barcode reader to the USB ports on the rear of the Dock if necessary.

Installing the External Parameter Module

If an external parameter module is needed, refer to section 2.8.1 Installing the N1 or External Parameter Module into the Modular Rack for installation.

Turning on the Monitor

Before beginning measurements, turn on the monitor, perform the following inspections:

1.

Check the monitor for any mechanical damage. Make sure that all external cables, plug-ins and accessories are properly connected.

2.

Connect the monitor to the AC power source using AC adapter or Dock. Make sure the battery power is sufficient if the monitor is powered by the battery.

3.

Press the power switch to turn on the monitor.

When the monitor is turned on, the alarms are paused for two minutes. Then the alarm system is activated.

CAUTION

Check that visual and auditory alarm signals are presented correctly when the equipment is powered on.

Do not use the monitor for any monitoring procedure on a patient if you suspect it is not working properly, or if it is mechanically damaged. Contact the service personnel or Mindray.

NOTE

For first use, connect the monitor to the AC power source and then turn on the monitor to activate the battery.

The time for the monitor to warm up from the minimum storage temperature between uses until the monitor is ready for its intended use is 10 minutes when the ambient temperature is 20 °C.

The time for the monitor to cool down from the maximum storage temperature between uses until the monitor is ready for its intended use is 10 minutes when the ambient temperature is 20 °C.

BeneVision N1 Patient Monitor Operator’s Manual 3 - 3

3.5

3.5.1

Operation and Navigation

Everything needed to operate the monitor is on its screen. Almost every element on the screen is interactive.

Screen elements include parameter values, waveforms, quick keys, information fields, alarms fields, dialogs, and menus. Often you can access the same element in different ways. For example, you can access a parameter dialog by selecting the corresponding numeric area or waveform area, or by selecting the Main Menu quick key

from the Parameters column select Setup .

Using the Touchscreen

You can use the touchscreen to select a screen element by pressing directly on the monitor’s screen.

3.5.1.1

Tapping or Swiping across the Screen

■ Tapping the screen

◆ To select an item from menus or lists or select a quick key, tap on it with your finger.

◆ To enter a parameter menu, tap the corresponding numeric area or waveform area. For example, select the ECG numeric area or waveform area to enter the ECG menu.

Swiping the screen with a single finger

To scroll through a list or a menu, swipe up or down.

If an external display is connected, to show or expand the Minitrends screen or the EWS screen on the external display, swipe right across the corresponding screen.

◆ If an external display is connected, to contract or hide the Minitrends screen or the EWS screen on the external display, swipe left across the corresponding screen.

Swiping across the screen with two fingers

If an external display is connected, to switch to another screen, swipe left or right across the screen.

For example, on the Normal screen, swipe with two fingers from left to right to switch to the

Minitrends screen.

To discharge a patient, swipe from top to bottom.

3.5.1.2

Locking the Touchscreen

To avoid accidental use, the touchscreen is locked in the following situations:

The touchscreen is not used in 60 seconds when the N1 runs on battery and is not connected to an external display.

Select the Unlock quick key , and swipe the slider up as instructed.

When the touchscreen is locked, the quick key changes to on the touchscreen and swipe the slider up as instructed.

. To unlock the touchscreen, touch anywhere

NOTE

Wipe off any water on the touchscreen in case of rain or water spray.

3.5.2

Using the On-Screen Keyboard

The on-screen keyboard enables information entry:

Enter the information by selecting one character after another.

Select the Backspace key

Select the Caps Lock key

Select the Enter key

to delete single characters or select

to access uppercase letters.

to delete the entire entry.

to confirm the entry and close the on-screen keyboard.

If a conventional keyboard is connected to the monitor, you can use it instead of, or in combination with, the onscreen keyboard.

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3.5.3

Using the Barcode Reader

The monitor supports both a linear (1D) barcode reader and two-dimensional (2D) barcode reader. The barcode reader is connected to the monitor through the USB connector on the rear of the Dock.

NOTE

Use the Mindray custom barcode reader to obtain all the available patient information from both the 2D and 1D barcodes. Using other barcode readers can only output the patient’s medical record number (MRN) and visit number.

3.5.3.1

Clearing Old Data Formats (for the Mindray Custom 2D Barcode Reader)

If you are using the Mindray custom 2D barcode reader (Model HS-1R or HS-1M), before using the it for the first time, clear old data formats and configure the barcode reader. To do so, follow this procedure:

1.

Scan the engineering barcode to clear the previous data format.

2.

Scan the 2D engineering barcode which contains the hospital’s data format.

NOTE

Contact the scanner manufacturer or Mindray to obtain the barcodes for clearing data formats and programming the hospital’s data format.

3.6

Screen Display

The following figure shows the normal screen:

(1) (2) (3) (4)

(5) (6)

(10)

(7)

(9)

(8)

(1)

(2)

(3)

(4)

(5)

(6)

Patient information area: displays patient category and gender. The displayed patient information is configurable. Selecting this area enters the Patient Management dialog. For more information, see 5.2.2 Editing

Patient Information .

Patient information area: displays patient information, including department, room number, bed number, and so on. The displayed patient information is configurable. Selecting this area enters the Patient Management dialog. For more information, see 5.2.2 Editing Patient Information .

Technical alarm information area: displays technical alarm message or prompt message.

The current configuration: displays the name of the configuration that can be loaded from the main menu.

Physiological alarm information area: displays physiological alarm message.

System status information area: displays alarm symbol, battery status, network status, currently connected CMS,

and system time. For more information, see 3.6.1 On-screen Symbols .

BeneVision N1 Patient Monitor Operator’s Manual 3 - 5

3.6.1

(7)

(8)

Quick key area: displays quick keys.

Parameter numerics area: displays parameter values, alarm limits, and alarm status. This area can also display the parameter list. For more information, see

3.9.3 Displaying the Parameter List

. Selecting a parameter numeric block enters the corresponding parameter dialog. Selecting the parameter list enters Tabular Trends review.

(9) Parameter waveform/numerics area: unique area of the screen that can be configured to display either parameter numerics or parameter waveforms. Depending on the configuration, the tiles take on the characteristics of either area (8) or area (10).

(10) Parameter waveform area: displays parameter waveforms, measurement ranges, and magnification. Selecting a waveform enters the corresponding parameter dialog.

On-screen Symbols

The following table lists the on-screen symbols displayed on the system status information area:

Symbol Description

Adult, male

Symbol Description

Adult, female

Pediatric, male

Neonate, male

Wireless network is connected. The solid part indicates network signal strength.

Wired network is connected.

Pediatric, female

Neonate, female

Wireless network is not connected.

Wired network is not connected.

All the alarms are paused.

Audible alarm tones are paused.

The alarm system is reset.

The battery has low power and needs to be charged.

The battery is being charged.

Individual physiological alarms are turned off or the monitor is in the alarm off status.

Audible alarm tones are turned off.

The battery is working correctly. The green portion represents the remaining charge.

The battery has critically low charge and needs to be charged immediately. Otherwise, the monitor will automatically shut down soon.

No battery is installed.

Battery fault, battery communication fault, or battery charging fault. Contact service personnel for help.

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3.6.2

Dialogs

All dialogs have similar style and structure, see the figure below:

(1)

(2)

(2)

(4)

(5)

(6)

(3)

3.6.3

(4) Exit button: closes the current dialog.

(5) Main body area: includes dialog items and options.

(6) Switch:

Green: the switch is on.

Gray: the switch is off.

Quick Keys of N1

The monitor provides quick keys for you to quickly access some functions. The quick key area is located at the right of the screen. The quick key area displays 5 quick keys.

You can also swipe down on the quick key area for more quick keys.The following table shows available quick keys.

The following table shows available quick keys.

Symbol Label

Main Menu

Function

Enters the main menu.

Symbol Label

Alarm Reset

Function

Resets the alarm system.

Alarm Pause

Screen Setup

Pauses the physiological alarm system (Availability depends on configuration of Pause in Maintenance

→ Alarm → Pause/Reset dialog).

Enters the Screen Setup dialog.

Audio Pause Pauses alarm tone

(Availability depends on configuration of Pause in

Maintenance → Alarm →

Pause/Reset dialog).

Standby Enters the standby mode.

BeneVision N1 Patient Monitor Operator’s Manual 3 - 7

Symbol Label

Manual Event

Function

Manually saves an event into the Events list.

Symbol Label

Print

Function

Starts printing a real-time report.

NIBP Start/

Stop

Lock

Starts an NIBP measurement or stops the current NIBP measurement.

Selects and operates as instructed to unlock the touchscreen

NIBP Measure Opens the NIBP Measure interval options.

Unlock Selects and operates as instructed to lock the touchscreen

3.7

Operating Modes

The monitor provides different operating modes. This section describes the different monitoring modes and standby modes.

3.7.1

3.7.2

3.7.3

Monitoring Mode

The monitoring mode is the most frequently used clinical mode for patient monitoring. When the monitor is turned on, it automatically enters the monitoring mode.

Module Mode

When the N1 is connected to the host monitor, the N1 enters the module mode. For connection of the N1 and the host monitor, see section 2.9 N1 in Use with a Host Monitor . The N1 monitor has the following features when it enters the module mode:

■ The patient information, parameter setup, and alarm setup of the N1 and the host monitor will be synchronized. For data transfer strategy, see the operator’s manual of the host monitor.

The N1 can still store the parameter data and the alarm events.

The N1 receives and stores the parameter trends data from the host monitor.

All audible sounds of the N1 are off.

Wired and wireless network of the N1 are not available.

The alarm indications of the battery related alarms of the N1 are given by the host monitor.

Turning on or off the host monitor simultaneously powers on or off the N1.

The main screen of the N1is off when it is connected to the host monitor through the SMR or the module rack of the host monitor.

The N1 resumes to monitor mode when it is disconnected from the host monitor.

Privacy Mode

The privacy mode is a special clinical monitoring mode. In the privacy mode, the monitor does not display patient information and monitoring data. This provides controlled access to patient data and ensures confidentiality.

The privacy mode is only available when the patient admitted by the monitor is also monitored by the CMS. The monitor continues monitoring the patient, but patient data is only visible at the CMS.

3.7.3.1

Entering the Privacy Mode

To enter the privacy mode, select the Main Menu quick key → from the Display column select Privacy Mode

select Ok .

The monitor has the following features after entering the privacy mode:

The screen turns blank.

Except for the low battery alarm, the monitor inactivates alarm tones and alarm lights for all other alarms.

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■ The monitor suppresses all system sounds, including heart beat tone, pulse tone, and prompt tone.

WARNING

. •

In the privacy mode, all audible alarms are suppressed and the alarm light is deactivated at the monitor. Alarms are presented only at the CMS. Pay attention to potential risk.

NOTE

The privacy mode is not available if the Department is set to OR.

You cannot enter the privacy mode if a low battery alarm is active.

3.7.3.2

Exiting the Privacy Mode

The monitor automatically exit the privacy mode in any of the following situations:

The monitor disconnects from the CMS.

The low battery alarm occurs.

You can also operate the touchscreen, mouse, or keyboard to manually exit the privacy mode.

3.7.4

Night Mode

The night mode is a special clinical monitoring mode. The night mode reduces screen brightness, sound volumes, and pauses NIBP measurements. To avoid disturbing the patient, you can use the night mode.

3.7.4.1

Entering the Night Mode

To enter the night mode, follow this procedure:

1.

Select the Main Menu quick key

from the Display column select Night Mode .

2.

Change the night mode settings if necessary.

3.

Select Enter Night Mode .

The night mode settings are as follows by default:

Brightness

Alarm Volume

QRS Volume

Key Volume

NIBP End Tone

Stop NIBP :

: 1

:

:

0

1

Off

:

:

2

Off

CAUTION

Verify the night mode settings before entering the night mode. Pay attention to the potential risk if the setting value is low.

3.7.4.2

Exiting the Night Mode

To cancel the night mode, follow this procedure:

1.

Select the Main Menu quick key

from the Display column select Exit Night Mode .

2.

Select Ok .

NOTE

If the monitor is connected to the CMS, it automatically exits the night mode if disconnected from the CMS.

BeneVision N1 Patient Monitor Operator’s Manual 3 - 9

The monitor resumes the previous settings after exiting the night mode.

3.7.5

Standby Mode

You can temperately stops patient monitoring without switching off the monitor by entering the standby mode.

3.7.5.1

Entering the Standby Mode

1.

Select the Standby quick key, or select the Main Menu quick key

from the Patient Management column select Standby .

2.

Define where the patient is by selecting a location in the drop down list when the monitor enters the standby mode.

3.

Select Ok .

The monitor behaves as follows after entering the standby mode:

Stops all parameter measurements.

Disables all the alarms and prompt messages, except for the battery low alarm.

Turns screen brightness to the dimmest after entering the standby mode for 30 seconds.

WARNING

Pay attention to the potential risk of placing the monitor to standby. In the standby mode, the monitor stops all parameter measurements and disable all the alarm indications, except for the battery low alarm.

3.7.5.2

Changing the Patient Location at Standby

To change the patient’s location, select patient location from the Standby screen.

3.7.5.3

Exiting the Standby Mode

To exit the standby mode, choose any of the following ways:

Select

Select

Resume Monitor to exit the standby mode and resume monitoring the current patient.

Discharge Patient to discharge the current patient.

If the monitor automatically enters the standby mode after a patient is discharged, choose any of the following ways to exit the standby mode:

Select

Select

Monitor to exit the standby mode and admit a new patient.

Patient Management to enter the patient information for preparing to admit a new patient.

When the monitor exits Standby mode and resumes monitoring, the alarms are paused for two minutes, after which the alarm system is activated.

3.7.6

Outdoor Mode

The outdoor mode is intended for transferring patients outdoors. The monitor behaves as follows after entering the outdoor mode:

The parameter color is white and unchangeable.

The screen brightness is automatically changed to 10.

3.7.6.1

Entering the Outdoor Mode

To enter the outdoor mode, select the Main quick key → from the Display column select Enter Outdoor Mode .

NOTE

The monitor enters the outdoor mode automatically if the strength of ambient light is greater than the threshold.

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3.7.6.2

Exiting the Outdoor Mode

When Enter Outdoor Mode is set to Manual , select the Main Menu quick key → from the Display column select Exit Outdoor Mode .

The monitor automatically exits the outdoor mode in the following situation:

The monitor is connected to a host monitor.

The strength of ambient light is lower than the threshold when Enter Outdoor Mode is set to Auto .

3.7.7

Discharge Mode

The discharge mode is a special standby mode after a patient is discharged.

3.8

Configuring the Monitor

Configure the monitor before putting it in use.

3.8.1

Setting the Date and Time

To set the system time, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Time .

2.

Set Date and Time .

3.

Set Date Format .

4.

If you want to use the 12-hour mode, switch off 24 Hour Time .

5.

If you want to use daylight saving time, switch on Daylight Saving Time . You can manually switch on or off the daylight saving time only when the auto daylight saving time function is disabled. For more information, see 21.7 Enabling Auto Daylight Savings Time for details.

If the monitor is connected to a central monitoring system (CMS) or hospital clinical system (HIS), the date and time are automatically taken from the CMS. In this case, you cannot change the date and time on the monitor.

CAUTION

Changing the date and time affects the storage of trends and events and may result in loss of data.

3.8.2

3.8.3

3.9

Adjusting the Screen Brightness

To adjust the screen brightness, follow this procedure:

1.

Access Display in either of the following ways:

◆ Select the Screen Setup quick key → select the Display tab.

◆ Select the Main Menu quick key → from the Display column select Display .

2.

Set Brightness . If Brightness is set to Auto , the monitor automatically adjust the screen brightness according to the ambient light.

Adjusting the Key Volume

To adjust the key volume, follow this procedure:

1.

Select the Main Menu quick key

→ from the Display column select Display .

2.

Set the Key Volume .

General Operation

This section describes the operations that are generally used when monitoring a patient.

BeneVision N1 Patient Monitor Operator’s Manual 3 - 11

3.9.1

Switching On or Off a Parameter

You can manually switch on or off a parameter when its module is connected. If setting parameter switches is not password protected, follow this procedure to set parameter switches:

1.

Access Parameters On/Off in either of the following ways:

◆ Select the Screen Setup quick key → select the Parameters On/Off tab.

◆ Select the Main Menu quick key → from the Parameters column select Parameters On/Off .

2.

Switch on or off desired parameters.

When a parameter is switched off, the monitor stops data acquisition and alarming for this measurement.

NOTE

When a parameter is manually switched off even, you cannot monitor this parameter if related accessories of this parameter are connected.

3.9.2

3.9.3

3.9.4

Displaying Parameter Numerics and Waveforms

You can configure the parameter numerics, waveforms, and their sequence displayed on the normal screen. To do so, follow this procedure:

1.

Access Tile Layout in either of the following ways:

◆ Select the Screen Setup quick key

select the Tile Layout tab.

◆ Select the Main Menu quick key

→ from the Display column select Tile Layout .

2.

Select a parameter numeric area or waveform area, and then from the popup list select an element you want to display in this area. The parameters and waveforms you did not select will not displayed.

Displaying the Parameter List

You can display the trends of HR, SpO

2

, RR, and NIBP/IBP in the parameter numerics area. To do so, follow this procedure:

1.

Access Tile Layout in either of the following ways:

◆ Select the Screen Setup quick key

select the Tile Layout tab.

◆ Select the Main Menu quick key → from the Display column select Tile Layout .

2.

Select the parameter numerics area where you want to display the parameter list, and then from the popup list select Parameter List .

Accessing Parameter Setup Dialogs

Each parameter has a setup dialog in which you can adjust the alarm and parameter settings. You can enter a parameter setup dialog by using any of the following methods:

Select the parameter numeric area or waveform area.

Press the setup hard key on the module front of the CO

2

module.

Select the Parameters Setup quick key , and then select the desired parameter .

Select the Main Menu quick key

from the Parameters column select Setup

select the desired parameter .

NOTE

In this manual, we always use the first method to enter the setup dialog. But you can use any method you prefer.

3.9.5

Changing Measurement Colors

You can set the color of measurement values and waveforms for each parameter. To do so, follow this procedure:

1.

Select Main Menu quick key → from the Parameters column select Parameter Color .

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3.9.6

3.9.7

2.

Select the Current tab and set the colors of the currently monitoring measurement values and waveforms.

3.

Select the All tab and set the colors of measurement values and waveforms for all parameters.

Choosing a Screen

The monitor enters the normal screen after it is powered on. The normal screen is most frequently used for patient monitoring. You can also select other screens. To do so, follow this procedure:

1.

Access Choose Screen in either of the following ways:

◆ Select the Screen Setup quick key.

◆ Select the Main Menu quick key → from the Display column select Choose Screen .

2.

Select the desired screen.

Selecting the Big Numerics Screen

The big numerics screen displays parameter numerics in big font size. You can configure the parameters and their layout on the big numeric screen. Quickly switch between the normal screen and the big numeric screen by swiping left or right on the touchscreen with two fingers. You can also select the big numeric screen by proceeding as follows:

1.

Access Choose Screen in either of the following ways:

◆ Select the Screen Setup quick key.

◆ Select the Main Menu quick key → from the Display column select Choose Screen .

2.

Select Big Numerics .

3.

Select Big Numerics tab.

4.

Select a parameter numeric area or waveform area, and then from the popup list select an element to display in this area.

3.10

Connecting the CMS

You can connect the monitor to the BeneVision CMS through wired LAN or wireless LAN. When connected to the

CMS, the system provides the following function.

The monitor can transmit parameter values, waveforms, alarms, and events to the CMS. From the CMS, you can check the patient’s monitoring data and alarms.

The monitor can transmit parameter values and alarms from the connected external devices to the CMS.

From the CMS you can check the patient’s monitoring data and alarms obtained from the connected external devices.

Patient information, alarm settings, and alarm status can be synchronized between the monitor and the

CMS.

You can start or stop NIBP measurements from the CMS.

In case of network disconnection, the monitor can transmit the offline data to the CMS when the network is reconnected.

For more information on the CMS, see the operator’s manual of corresponding central monitoring system.

To select a CMS, select the system status information area at the top right corner of the main screen. Select the desired CMS from the popup CMS list.

NOTE

You can select CMS only when the Select CMS switch is on. For more information, see

21.12.4 Enabling Selecting a CMS .

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3.11

Connecting the eGateway

You can connect the monitor to the eGateway through wired LAN or wireless LAN to implement interaction between the monitor and external devices. When connected to the eGateway, the system provides the following functions:

The monitor can transmit parameter values, waveforms, alarm settings, and events to the eGateway.

The monitor can transmit parameter values and alarm settings received from the BeneLink-connected external devices to the eGateway.

Clock can be synchronized between the monitor and the eGateway.

3.12

Connecting the Wireless Network

You can add up to five wireless networks for the monitor. For more information, see

21.12.2 Setting the Wireless

Network

.

If connecting the current wireless network fails, the monitor automatically connects other wireless networks in the order when they were added.

To manually switch the wireless network, from the system status information area on the top right conner of the screen select , and select the desired wireless network.

3.13

Disconnecting the Wireless Network

To disconnect the wireless network manually, follow this procedure:

1.

Swipe the screen from top down with a single finger.

2.

Select .

To reconnect the wireless network after it is disconnected manually, follow this procedure:

1.

Swipe the screen from top down with a single finger.

2.

Select .

3.14

Turning Off the Monitor

Before turning off the monitor, perform the following check:

1.

Ensure that monitoring of the patient has been completed.

2.

Disconnect the cables and sensors from the patient.

3.

Save or clear the patient data as required.

To turn off the monitor, press and hold the power switch for 3 seconds.

CAUTION

Press and hold the power switch for no less than 10 seconds to forcibly shut down the monitor if it could not be shut down normally. This may cause loss of patient data.

NOTE

Turning off the monitor does not disconnect the monitor from the AC mains. To completely disconnect the power supply, unplug the power cord.

In case of a temporary power failure, if the power is restored within 30 minutes, monitoring will resume with all active settings unchanged. If the monitor is without power for more than 30 minutes, it behaves the same as if it were normally turned off.

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4

Using the External Display

4.1

Using the External Display

The N1 can be connected to an external display through the VGA connector of the Dock. When the external display is connected, you can monitor a patient’s condition either through the N1 or through the external display.

The external display can be configured as independent display enabling it to be configured to show different information than the N1. For the configuration of the independent external display, see section 21.15.4 Setting the External Display .

The following screens or functions can be viewed and operated only on the independent external display:

Minitrends Screen

OxyCRG Screen

Remote View Screen

ECG Half-Screen

PAWP Screen

Calculations

EWS

GCS

ST Graphic

Targeted Goal

NOTE

The external display can share the mouse or keyboard with the monitor. If the mouse or keyboard are needed, connect them to the USB connector of the Dock.

4.1.1

4.1.2

Connecting the N1 to the External Display

To connect the external display, follow this procedure:

1.

Connect the Dock and the external display using the VGA cable.

2.

Connect the Dock and the external display using the USB cable accompanying the external display.

3.

Connect the external display to the AC mains and turn on the display.

4.

Connect the N1 to the Dock.

External Display Troubleshooting

Problem Corrective Actions

Image offset

No image or the image displays abnormally • Check that the external display is properly connected to the AC mains and is powered on.

• Check that the VGA cable is properly connected.

• Remove the N1 from the Dock and reconnect it.

Touchscreen failure

Adjust the external display by using the auto adjust function or adjust the external display manually.

Check that both ends of the USB cable accompanying the external display are connected properly to the Dock and the external display.

BeneVision N1 Patient Monitor Operator’s Manual 4 - 1

4.1.3

CAUTION

Use only the specified display. Using unspecified displays may result in unexpected problems.

Quick keys of the independent external display

The following table displays the quick keys that are available for the independent external display.

Symbol Label

Main Menu

Function

Enters the main menu.

Symbol Label

Alarm Reset

Function

Resets the alarm system.

Alarm Pause

Screen Setup

Pauses the physiological alarm system (Availability depends on configuration of Pause in Maintenance

→ Alarm → Pause/Reset dialog).

Enters the Screen Setup dialog.

Manual Event Manually saves an event into the Events list.

NIBP Start/

Stop

NIBP STAT

Alarm Setup

Starts an NIBP measurement or stops the current NIBP measurement.

Starts a five-minute continuous NIBP measurement.

Enters the Alarm dialog.

Zero IBP Enters the Zero IBP dialog.

Parameters

Setup

Enters the Parameters

Setup dialog.

Review

OxyCRG

Enters the Review dialog to review historical data.

Opens the OxyCRG screen.

Privacy Mode Enters the privacy mode.

Audio Pause Pauses alarm tone

(Availability depends on configuration of Pause in

Maintenance → Alarm →

Pause/Reset dialog).

Standby Enters the standby mode.

Print Starts printing a real-time report.

NIBP Measure Opens the NIBP Measure interval options.

NIBP Stop All Stops all NIBP measurements.

More Shows more quick keys.

PAWP Opens the PAWP screen.

Remote View Opens the Remote View screen to view other patients.

Minitrends Opens the Minitrends screen.

ECG Full-

Screen

Opens the ECG full screen.

Night Mode Enters the night mode.

4 - 2 BeneVision N1 Patient Monitor Operator’s Manual

Symbol Label

CPB Mode

Function

Enters the CPB mode.

Volume Enters dialog.

Symbol Label

Intubation

Mode

Function

Enters the intubation mode.

Freeze Freezes waveforms.

Calculations Enters the Calculations dialog.

Patient

Management

Enters the Patient

Management dialog.

Venipuncture Inflates the NIBP cuff to help venous puncture.

GCS Enters the GCS dialog.

Discharge

Patient

Targeted Goal

Enters the Discharge

Patient dialog to discharge the patient and restore pre-configured default settings.

Opens the Targeted Goal screen.

Load Config Enters the Load Config dialog.

ECG Lead/

Gain

Enters the ECG Lead/Gain dialog.

EWS Opens the EWS screen.

SepsisSight Enters the SepsisSight dialog.

Discharged

Patients

Enters the Discharged

Patients dialog and displays previously discharged patients.

End Case

Report

Prints the selected end case reports

4.1.4

4.2

4.2.1

Configuring the Displayed Quick Keys (only available when the N1 is used with the independent external display)

To select the quick keys you want to display, follow this procedure:

1.

Access Quick Keys in either of the following ways:

◆ Select the Screen Setup quick key → Select the Quick Keys tab.

◆ Select the Main Menu quick key → from the Display column select Quick Keys .

2.

Select the Current tab to configure the quick keys you want to display on the screen: From the top of this page, select a block where you want to show a certain quick key, and then select the quick key from the quick key list. For example, if you want to show the Screen Setup quick key at the first block, select the first block, and then select Screen Setup from the list.

3.

Select the More tab to configure the quick keys you want to display when the More quick key is selected.

Minitrends Screen

The Minitrends screen shows the recent graphic trends of parameters.

Entering the Minitrends Screen

Choose one of the following methods to enter the Minitrends screen:

■ Swipe left or right on the touchscreen with two fingers to switch among the Minitrends screen, normal screen, and the big numerics screen.

BeneVision N1 Patient Monitor Operator’s Manual 4 - 3

4.2.2

Select the Minitrends quick key.

Select the Screen Setup quick key → Select the Choose Screen tab → select Minitrends .

Select the Main Menu quick key → from the Display column select Choose Screen → select Minitrends .

For adult and pediatric patients, when the Minitrends screen is hidden as following methods to quickly enter the Minitrends screen.

, you can also choose one of the

Swipe left or right across the touchscreen with two fingers until you switch to the Minitrends screen.

Swipe right across the touchscreen with a single finger.

Select the button .

The Display of Minitrends Screen

The following figure shows the minitrends screen. Your display may be configured to look slightly different.

(3)

(1)

(4)

(5)

4.2.3

(6)

(2)

(1)

(2)

(3)

(4)

(5)

(6)

Scale

Routine Vital button. If the department is set to OR , then the Baseline button is displayed.

Routine Vital/Baseline

Select this button to view the long trends, or contract the long trends screen to the Minitrends screen.

Time line

Alarm statistic area

Viewing the Long Trends

To expand the Minitrends screen to view the long trends, choose either of the following ways:

Select the button.

Swipe right across the Minitrends screen with a finger.

4 - 4 BeneVision N1 Patient Monitor Operator’s Manual

4.2.4

4.2.5

4.2.6

4.2.7

4.2.8

Setting Minitrends Parameters

To set parameters, follow this procedure:

1.

Enter the Minitrends screen.

2.

Select the Setup button.

3.

Set parameters. If you want to use the default parameters, select Default Parameter .

Setting the Minitrend Length

To set the Minitrend length, follow this procedure:

1.

Enter the Minitrends screen.

2.

Select the Setup button.

3.

Set the Minitrend Length .

Setting the Alarm Statistics Switch

The Minitrends screen can be configured to display the statistic number of physiological alarms in its lower half screen. To set the alarm statistics switch, follow this procedure:

1.

Enter the Minitrends screen.

2.

Select the Setup button.

3.

Switch on or off the Alarm Statistics switch.

Setting the Alarm Statistics Duration

The time length within which the alarms statistics are made is configurable. To set the alarm statistics length, follow this procedure:

1.

Enter the Minitrends screen.

2.

Select the Setup button.

3.

Set Alarm Statistics Duration .

Routine Vital/Baseline

The Routine vital/Baseline function is used for marking the parameter measurements of certain moment for later reference. If the department is set to OR , then the Baseline button is available. For other departments, the

Routine Vital button is available.

4.2.8.1

Manually Marking the Routine Vital/Baseline

To manually mark the Routine Vital/Baseline, follow this procedure:

1.

Enter the Minitrends screen.

2.

Select the Routine Vital button or Baseline button.

NOTE

If you do not see the Baseline button or Routine Vital button in the Minitrends screen, you can select the Setup button and switch on the Baseline switch, or set the Routine Vital to Manual or Auto.

4.2.8.2

Configuring Automatic Routine Vital Settings

The monitor can automatically mark the routine vital sign values. To enable this function, follow this procedure:

1.

Enter the Minitrends screen.

2.

Select the Setup button.

3.

Select Auto from the dropdown list of Routine Vital .

4.

Select Time to set the time for marking the first routine vital sign values.

BeneVision N1 Patient Monitor Operator’s Manual 4 - 5

4.3

4.3.1

4.3.2

5.

Select Interval to set the interval for marking the routine vital sign values.

The OxyCRG Screen

The monitor displays the OxyCRG screen by default when the neonatology department is selected. The OxyCRG screen is available in any department setting, but only when the patient size is set to Neo. This screen displays 6minute HR, SpO

2

trends, CO

2

/Resp compressed waveform, ABD parameters, and the latest ABD events.

The OxyCRG function is intended for neonatal patents only.

Entering the OxyCRG Screen

To enter the OxyCRG screen, choose any of the following ways:

Swipe left or right on the touchscreen with two fingers to switch to the OxyCRG screen.

Select the OxyCRG quick key.

Select the Screen Setup quick key

select the Choose Screen tab

select OxyCRG .

Select the Main Menu quick key

from the Display column select Choose Screen

select OxyCRG .

The Display of the OxyCRG Screen

The following figure shows the OxyCRG screen. Your display may be configured to look slightly different.

(8) (7)

(1)

(6)

(2)

4.3.3

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(3) (4) (5)

HR, SpO

2

trend

Resp/CO

2

compressed waveform

Event time

Event type

Parameter values of ABD events

ABD event list: displays the latest red ABD events. Selecting the ABD event list area enters the OxyCRG review page.

Mark button: opens the Mark dialog to edit the events.

ABD event prompt area: displays parameter values of currently active OxyCRG events.

OxyCRG Events

The following table lists the ABD events and their criteria:

Event type

A

Description

Zero RR event: the zero RR duration exceeds the threshold.

• A20: the zero RR duration is greater or equal to 20 seconds.

• A15: the zero RR duration is between 15 to 20 seconds (excluding 20 seconds).

• A10: the zero RR duration is between 10 to 15 seconds (excluding 15 seconds).

Remarks

A20 is a red event

4 - 6 BeneVision N1 Patient Monitor Operator’s Manual

B

D

BD

AB

AD

ABD

Event type Description

Low Heart Rate event: the duration of low heart rate exceeds the threshold.

Low SpO2 event: the duration of SpO2 Desat exceeds the threshold.

Low Heart Rate and low SpO2 happen at the same time.

Zero RR and Low Heart Rate happens at the same time.

Zero RR and low SpO2 happen at the same time.

Zero RR, Low Heart Rate, and low SpO2 happen at the same time.

Remarks

/

/

/

Red event

Red event

Red event

NOTE

The monitor records all ABD events for OxyCRG review, but only red events displays in the ABD list of the OxyCRG screen.

4.3.4

4.3.5

4.3.6

4.3.7

4.4

The Display of the ABD Event Area

The ABD event area displays parameter values of currently active OxyCRG events and lists the latest red ABD events.

Setting OxyCRG Parameters

Select parameter trends or compressed waveform to set parameters and the compressed waveform you want to display. The selected parameters will be used for ABD event calculation.

Setting the Threshold of ABD Events

Select any parameter trend or the compressed waveform to perform the following setup:

Set the threshold of ABD events.

Set Event Storage Format :

◆ 1 min+3 min : stores data one minute before and three minutes after the event.

◆ 3 min+1 min : stores data three minutes before and one minute after the event.

◆ 2 min+2 min : stores data two minutes before and two minutes after the event.

The stored data includes the trends of the OxyCRG parameters, compressed waveform, alarm thresholds, NIBP, and Temp measurements.

Editing ABD Events

To edit ABD events, follow this procedure:

1.

Select the Mark button to enter the Mark dialog box.

2.

Drag the event list upwards and downwards to select the desired event.

3.

Select the patient’s status when the event happened.

4.

Select Save .

The Targeted Goal Screen

If you are concerned with specific parameters and their trends, you can use the Targeted Goal screen. The

Targeted Goal screen focuses on the target parameter and displays parameter measurements in big numerics.

You can easily identify whether parameter target is reached via a dashboard and review the statistics of the target parameter by sections.

The Targeted Goal screen displays parameter measurements and waveforms of ECG, SpO

2

, IBP, PI, PR, CO

2

, Resp,

NIBP, and Temp. You can define the target parameter and secondary parameters. The measurements of these parameters displays in big numerics.

BeneVision N1 Patient Monitor Operator’s Manual 4 - 7

4.4.1

4.4.2

Entering the Targeted Goal Screen

To enter the Targeted Goal screen, choose any of the following ways:

Select the Screen Setup quick key

select the Choose Screen tab

select Targeted Goal screen.

Select the Main Menu quick key

from the Display column select Choose Screen

select Targeted

Goal Screen.

■ If the Patient Category is set to Neo , swipe left or right on the touchscreen with two fingers to switch to the Targeted Goal screen.

The Display of the Targeted Goal Screen

The following figure shows the Targeted Goal screen. Your display may be configured to look slightly different.

(4)

(1)

(2) (5)

(3)

(6)

4.4.3

(1) Parameter trends area: displays trends of the target parameter and secondary parameters. If the target parameter is Art, this area only lists the trend of arterial pressure.

(2) Target parameter statistics area: displays the statistics of the target parameter by sections.

(3) Other parameter area: displays parameter measurements and alarm limits of parameters other than the target parameter and secondary parameters.

(4) Target parameter area: displays the measurement of the target parameter in big numerics, as well as its target range, and alarm limits.

• If the target parameter is Resp or PR, parameter source is also displayed.

• The dashboard shows the target range in green.

• The

△ pointer below the dashboard indicates the current measurement value.

(5) Secondary parameters area: displays parameter measurement of secondary parameters in big numerics, as well as waveforms and alarm limits. If secondary parameters are Resp and PR, parameter sources are also displayed.

(6) Target parameter waveform area: displays the waveform of the target parameter.

• If the target parameter is Resp or PR, the waveform of the source parameter is displayed.

• If the target parameter is ECG, the fist ECG waveform is displayed by default.

Configuring the Targeted Goal Screen Layout

To configure the parameter numerics, waveforms, and their sequence displayed on the Targeted Goal screen, follow this procedure:

1.

Access the Targeted Goal screen in either of the following ways:

◆ Select the Screen Setup quick key

select the Choose Screen tab

select Targeted Goal screen.

◆ Select the Main Menu quick key

from the Display column select Choose Screen

select

Targeted Goal Screen.

2.

Select a parameter numeric area or waveform area, and then from the popup list select an element to display in this area. The parameters and waveforms not selected will not displayed.

4 - 8 BeneVision N1 Patient Monitor Operator’s Manual

4.4.4

4.5

Operating the Targeted Goal Screen

You can access parameter setup and trends review from the Targeted Goal screen. To do so, follow this procedure:

Select the parameter trends area to enter the Tabular Trends review page.

Select the target parameter statistics area to enter the parameter statistics setup dialog. Set the range of each section and the target section.

Select the desired waveform area, parameter numeric area, or dashboard to enter corresponding parameter setup dialog.

Remote View

The patient alarm and real time physiological data of the N1 can be viewed by other networked monitors. When the external display is connected, you can also observe alarm conditions and view real time physiological data from patients on other networked monitoring devices.

A device from a remote site is called a remote device or bed. You can simultaneously watch up to 12 remote devices. You can also view waveforms of one remote device on the external display.

You can watch the remote devices in the Remote View screen, or the alarm watch tiles on the main screen.

In the Remote View screen, you can view real time parameters and waveforms from one specific device, and watch the alarms of other monitored devices at the same time.

NOTE

A particular monitor (for example Monitor #1) can be viewed by at most 32 remote devices at the same time, of which eight of those remote devices can watch Monitor #1’s waveforms.

4.5.1

4.5.2

Entering the Remote View Screen

To enter the Remote View screen, choose one of the following ways:

Select the Remote View quick key.

Select the bed at the alarm watch tile on the main screen. For more information, see 4.5.10.2 Displaying the

Alarm Watch Tile on the Main Screen .

Select the Screen Setup quick key

→ select the Choose Screen tab

→ select Remote View .

About the Remote View

The following figure shows the Remote View screen.

BeneVision N1 Patient Monitor Operator’s Manual 4 - 9

(1)

(2)

(3)

(1)

(2)

(3)

Alarm watch area

Displays all the monitored remote beds. Each bed displays the room number, bed number, connection status and alarm status. The background color indicates the alarm status on the corresponding bed.

Background Color Description

Green

Red

Yellow

Cyan

Grey

Main area

No alarm is occurring at the bed.

The remote device is disconnected or a high priority alarm is currently the highest alarm level on the bed. If the remote device is disconnected, the icon is displayed.

The medium priority alarm is currently the highest alarm level on the bed.

The low priority alarm is currently the highest alarm level on the bed.

The bed is in the standby mode.

Displays the patient’s information, alarm status and messages, waveforms, measurements, etc. of the selected bed.

This bed is called main bed.

Remote View setup button: select it to enters the Remote View setup menu.

WARNING

The data presented in the Remote View screen has a delay. Do not rely on this screen for real time data.

4.5.3

Adding a Bed

After adding the desired remote devices, then the alarms from these devices can be viewed on the monitor. To add a remote device, follow this procedure:

1.

Enter the Select Bed dialog. To do so, choose either of the following ways:

◆ In the Remote View screen, select Select Bed . For more information, see

4.5.1 Entering the Remote

View Screen

.

Select the icon at the alarm watch tile if the tile is configured to display on the main screen.

2.

In the Select Bed dialog, select a desired department. All the beds under this department will be listed.

3.

Select a desired tile at the A-W1 or A-W2 areas and then select a bed from the bed list. The selected bed will appear in the tile.

4 - 10 BeneVision N1 Patient Monitor Operator’s Manual

NOTE

The added bed is indicated by a check mark (√) at the left of the bed list.

4.5.4

4.5.5

4.5.6

4.5.7

Removing a Bed

To remove a remote device from remote monitoring, follow this procedure:

1.

Enter the Select Bed dialog. Choose either of the following ways:

In the Remote View screen, select Select Bed

. For more information, see 4.5.1 Entering the Remote

View Screen

.

◆ Select the icon in the alarm watch tile if the tile is configured to display on the main screen.

2.

In the Select Bed dialog, select a bed at the A-W1, A-W2 or A-W3 areas, and then select Clear Bed . If you want remove all beds, select Clear All Beds .

Displaying the Main Bed

In the Remote View screen, you can select a bed in the alarm watch area, then the main body of the Remote

View screen will display the real time monitoring screen of the device.

Saving a Manual Event

You can initiate a manual event on the remote monitor by selecting Manual Event in the Remote View screen.

Managing Alarms from Remote Devices

You can view and manage the alarms coming from remote devices.

If the monitor and remote devices have alarms at the same time, the monitor presents alarms according to the following rules:

If the alarm tone pattern for the monitor is same as that for the remote devices, the monitor prioritizes all the alarms and sounds the highest alarm tone.

If the alarm tone pattern for the monitor is different from that for the remote devices, the monitor sounds the alarms in their corresponding tone.

The monitor provides the same alarm tone pattern for the remote device alarms as those for the monitor alarms by default. You can change the alarm tone pattern of the remote monitor; see

21.3.5.5 Setting the Tone Pattern for

Alarms from Remote Devices

.

4.5.8

4.5.9

Resetting Alarms for Remote Devices

You can reset the alarms on the remote devices by selecting Alarm Reset in the Remote View screen. This

function needs to be enabled. For more information, see 21.3.5.1 Resetting Alarms for Remote Devices .

Selecting Beds By Care Group

If configured, the monitor automatically selects beds in the same care group during the shift of care groups in the CMS. To enable this function, follow this procedure:

1.

Enter the Select Bed window. Choose either of the following ways:

◆ In the Remote View window, select Select Bed . For more information, see

4.5.1 Entering the Remote

View Screen

for entering the Remote View window.

Select the icon in the alarm watch tile if the tile is configured to display on the main screen.

2.

In lower left corner of the Select Bed window, select Select Beds By Care Group .

4.5.10

Alarm Watch

The alarm watch function provides the alarm notification by color and sound.

■ The monitor sounds the highest priority alarm tone from all the monitored remote devices.

BeneVision N1 Patient Monitor Operator’s Manual 4 - 11

■ The monitor displays the highest priority alarm in corresponding background color for each bed at the following areas:

At the top of the Remote View . For more information, see

4.5.2 About the Remote View

for details.

◆ On the main screen. For more information, see

4.5.10.1 About Alarm Watch Tile for details.

4.5.10.1

About Alarm Watch Tile

The main screen can display two alarm watch tiles, namely A-W1 and A-W2. Each tile can accommodate up to six beds.

The following figure shows the alarm watch tiles.

(1) (1) (2)

(3) (5)

(3) (4)

(1)

(2)

(3)

(4)

(5)

Alarm watch tile label

Disconnection icon: when the remote device is disconnected, this icon displays at the tile, and the tile background color is red.

Select bed icon: select it to enter the Select Bed dialog.

More than one bed tile: when more than one bed is assigned to a tile, the tile displays the alarm status, connection status, etc.

One bed tile: when only one bed is assigned to a tile, the tile displays the parameter value and alarm message from this bed, etc.

The alarm watch tile is similar to alarm watch area in the Remote View.

For more information, see 4.5.2 About the

Remote View

.

4.5.10.2

Displaying the Alarm Watch Tile on the Main Screen

To configure the alarm watch tile to be displayed on the monitor’s main screen, follow this procedure:

1.

Select the Main Menu quick key → from the Display column select Choose Screen to enter the Screen

Setup dialog.

2.

Select the Tile Layout tab.

3.

Select the numeric area where you want to display the alarm watch tile, and then in the drop-down list, select Alarm Watch → A-W1 or A-W2 .

4.5.11

Auto Displaying the Alarm Bed

The monitor provides the function of automatically displaying the remote alarm bed. If this function is enabled, when a remote bed issues an alarm, the monitor automatically displays the monitoring information from this remote bed.

If multiple remote beds issue alarms, the monitor cyclically displays the alarm beds as per the preset interval and in the order of alarm time.

The auto displaying alarm bed function is disabled by default. To enable this function, follow this procedure:

1.

From the Remote View screen, select to enter the Remote View setup menu.

2.

Switch on Rollup Alarm Beds .

3.

Set Rollup Interval :

4 - 12 BeneVision N1 Patient Monitor Operator’s Manual

4.6

4.6.1

4.6.2

4.6.3

4.6.4

◆ Off : do not cyclically display the remote alarm beds. Once a new alarm is issued, the monitor automatically switches to the new alarm bed.

10 sec , 20 sec , or 30 sec : If multiple remote beds issue alarms, the monitor cyclically displays the alarm beds as per the preset interval and alarm priority in the order of alarm time.

4.

Set Alarm Priority:

◆ High Only: Only when a high priority alarm is issued, the monitor automatically switches to the alarm bed.

◆ High & Med: If Rollup Interval is set to Off and when a high priority alarm or medium priority alarm is issued, the monitor automatically switches to the alarm bed. If Rollup Interval is set to 10 sec , 20 sec , or 30 sec and multiple remote beds issue alarms, the monitor cyclically displays the alarm beds with higher priority in the order of alarm time. For example, if both high priority alarms or medium priority alarm are issued, only beds with high priority alarms are cyclically displayed.

Freezing Waveforms

During patient monitoring, the freeze feature allows you to freeze the currently displayed waveforms on the screen so that you can have a close examination of the patient’s status. Additionally, you can select any frozen waveform for recording.

Freezing Waveforms

To freeze waveforms, select the Freeze quick key. Except waveforms of the following screens, all displayed waveforms stop refreshing and scrolling after you select the Freeze quick key:

Minitrends screen oxyCRG screen

Remote View screen

EWS screen

Viewing Frozen Waveforms

To view the frozen waveforms, follow this procedure:

Select the or button in the Freeze dialog.

Slide the frozen waveform leftward or rightward.

At the lower right corner of the bottom most waveform displays the freeze time. The initial frozen time is 0 s .

With the waveforms scrolling, the freeze time changes at an interval of 1 second. For example, -2 s means the two seconds before the frozen time. This change will be applied for all waveforms on the screen.

NOTE

You can view the frozen waveforms of up to 120 seconds.

Unfreezing Waveforms

To unfreeze the frozen waveforms, select the button upper right corner of the Freeze dialog.

Printing Frozen Waveforms

To print the frozen waveforms, select the button at the upper left corner of the Freeze dialog.

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4 - 14 BeneVision N1 Patient Monitor Operator’s Manual

5

Managing Patients

5.1

5.2

Starting Monitoring a Patient

After turning on the monitor, follow this procedure to monitor a patient:

1.

Admit the patient.

2.

Check patient settings. Make sure that alarm limits, patient category and paced status, and so on, are appropriate for the patient. Change them if necessary.

3.

Perform desired measurements. For more information, see corresponding measurement chapters.

Admitting a Patient

The monitor admits a new patient in the following situations:

After a patient is manually discharged, the monitor automatically admits a new patient.

After being switched off for the selected time period, the monitor automatically discharges the previous patient and admits a new patient at startup.

If the monitor has not detected certain patient vital signs (ECG, SpO

2

, PR, RR, NIBP) for 30 minutes, it will prompt whether to start monitoring a new patient if any of the above vital signs are detected again.

Always input patient information as soon as the patient is admitted. For more information, see

5.2.2 Editing

Patient Information for details.

WARNING

The default Patient Category setting is Adult, and Paced setting is Unspecified. Set Paced and check if the Patient Category setting is correct for the patient.

For paced patients, set Paced to Yes. If it is incorrectly set to No, the monitor could mistake a pace pulse for a QRS and fail to alarm when the ECG signal is too weak.

For non-paced patients, set Paced to No.

5.2.1

5.2.2

Entering the Patient Management Dialog

Use any of the following methods to enter the Patient Management dialog:

Select the patient information area at the top left corner of the screen.

Select the Patient Management quick key (only available when the N1is used with the independent external display).

Select the Main Menu quick key → from the Patient Management column select Patient Management .

Editing Patient Information

Edit patient information after a patient has been admitted, or when patient information is incomplete, or when it is necessary to change patient information:

To edit patient information, follow this procedure:

1.

Enter the Patient Management

dialog. For more information, see 5.2.1 Entering the Patient Management

Dialog .

2.

Edit patient information as required.

If a barcode reader is connected to the monitor, scanning the patient’s barcode will enter the patient’s information.

BeneVision N1 Patient Monitor Operator’s Manual 5 - 1

5.2.3

5.2.4

NOTE

The monitor will reload the configuration if you change the patient category.

Loading Patient Information from the CMS

If the monitor is connected to the central monitoring system (CMS). You can load patient information from the

CMS to the monitor. To do so, follow this procedure:

1.

Enter the Find Patient dialog in either of the following ways:

◆ Select the Main Menu quick key → from the Patient Management column select Find Patient .

◆ From the Patient Management dialog select Find Patient .

2.

Input query criteria.

3.

Select Search . Then a list pops up, including all the patients that meet the query criteria.

4.

Select a patient from the patient list, and then select Admit . Corresponding patient information in the monitor will be updated.

NOTE

If ADT Query is switched on, input query criteria from the Discharged Patients page.

Loading Patient Information from the ADT Server

If the monitor is connected with the Admit-Discharge-Transfer (ADT) server through the eGateway. You can load patient information from ADT server to the monitor.

To do so, follow this procedure:

1.

Enter the Find Patient dialog in either of the following ways:

◆ Select the Main Menu quick key → from the Patient Management column select Find Patient .

◆ Select Find Patient from the Patient Management dialog.

2.

Input query criteria.

3.

Select Search . Then a list pops up, including all the patients that meet the query criteria.

4.

Select a patient from the patient list, and then select Admit . Corresponding patient information in the monitor will be updated.

NOTE

You can load patient information from the ADT server only when ADT Query is enabled. For more

information, see 21.12.9 Using the ADT Gateway .

The monitor can automatically upload the patient information from the ADT server when:

The configured keywords of the monitor and the eGateway are the same.

The IP address of the monitor is added to the eGateway configuration dialog.

Loading patient information from the ADT server updates only patient information in the monitor.

The patient’s monitoring data is not changed and the patient is not discharged.

5 - 2 BeneVision N1 Patient Monitor Operator’s Manual

5.3

5.4

5.5

5.6

5.7

Transferring Patient

Patient settings and data can be transferred from an N1 into a host monitor. The patient settings and data includes patient information, trend data, alarm events, and parameter alarm limits. The N1 also allows transfer of full disclosure data.

For detailed information about patient data transfer, refer to the user manual of the host monitor. For the connection of N1 and the host monitor, refer to section 2.9 N1 in Use with a Host Monitor .

WARNING

Do not discharge a patient on the bedside monitor before patient information is completely transferred. Discharging the patient during transfer will result in incomplete patient information.

NOTE

The system automatically switches on the HR/PR (high, low) alarms and lethal arrhythmia alarms after transferring the patient data.

Exporting Patient Data

To export the data of the current patient and discharged patients, follow this procedure:

1.

Connect the N1 to the Dock.

2.

Connect the USB drive to the Dock’s USB connector.

3.

Access the Discharged Patients dialog box by selecting the Main Menu quick key

→ from the Patient

Management column select Discharged Patients .

4.

From the patient list select desired patients.

5.

Select Export Patient Data .

Deleting Patient Data

To delete the data of discharged patients, follow this procedure:

1.

Access the Discharged Patients dialog box by selecting the Main Menu quick key

→ from the Patient

Management column select Discharged Patients .

2.

From the patient list select desired patients.

3.

Select Delete .

Stopping a Parameter Measurement

To stop monitoring a parameter, follow this procedure:

1.

Remove corresponding sensor from the patient.

2.

Disconnect the sensor from the patient cable.

3.

Disconnect the patient cable from the parameter module.

Discharging a Patient

Before monitoring a new patient, discharge the previous patient. The technical alarms are reset, and monitor

settings return to their defaults. For more information, see 20.3 Setting Default Patient Category

.

After a patient is discharged, the monitor automatically admits a new patient.

WARNING

Always discharge the previous patient before starting to monitor a new patient. Failure to do so can lead to data being associated with the wrong patient.

BeneVision N1 Patient Monitor Operator’s Manual 5 - 3

To manually discharge a patient, use any of the following methods to access the Discharge Patient dialog:

Swipe down the touchscreen with two fingers.

Select the Discharge Patient quick key (only available when the N1is used with the independent external display).

Select the patient information area at the top left corner of the screen → Discharge Patient .

Select the Patient Management quick key → Discharge Patient (only available when the N1is used with the independent external display).

Select the Main Menu quick key

from the

Select a button in the Discharge Patient dialog:

Patient Management column select Discharge .

Print End Case Report : prints the end case report when the patient is discharged.

Discharge : clears the waveform data of the current patient. The monitor loads the default configuration and goes to the standby mode. The current patient becomes a discharged patient.

Clear Patient Data : discharges the current patient and clears the waveform data. The monitor still uses the current configuration and does not go to the standby mode. The current patient becomes a discharged patient.

5 - 4 BeneVision N1 Patient Monitor Operator’s Manual

6

Alarms

6.1

6.2

Alarm Introduction

This chapter describes alarm functions and alarm settings.

Alarm Safety Information

WARNING

A potential hazard can exist if different alarm presets and default configuration settings are used for the same or similar equipment in the same care area, for example an intensive care unit or cardiac operating room.

If the monitor is connected to the central monitoring system (CMS) or other monitors, alarms can be presented and controlled remotely. Remote suspension, inhibition, or reset of monitor alarms via the CMS or other monitors may cause a potential hazard. For more information, see the operator’s manuals for the CMS and the other monitors.

The monitors in the care area may each have different alarm settings to suit different patients.

Always check that the alarm settings are appropriate for the patient before starting the monitoring.

Always make sure that necessary alarm limits are active and set according to the patient's clinical condition.

Setting alarm limits to extreme values may cause the alarm system to become ineffective. For example, setting the SpO

2

high alarm limit to 100%, is equivalent to switching the alarm off.

When the alarm sound is switched off, the monitor gives no alarm tones even if a new alarm occurs.

Be careful when considering to switch off the alarm sound. When the alarms are off or while alarm audio is paused either temporarily or indefinitely, observe the patient frequently.

When monitoring patients that are not continuously attended by a clinical operator, properly configure the alarm system and adjust alarm settings as per the patient's condition.

Do not rely exclusively on the audible alarm system for monitoring. Adjustment of alarm volume to a low level may result in a hazard to the patient.

6.3

6.3.1

6.3.2

Understanding the Alarms

Alarm Categories

The monitor has two different types of alarms: physiological alarms and technical alarms.

Physiological alarms are triggered by patient measurement exceeding the parameter limits, or by an abnormal patient conditions.

Technical alarms are triggered by an electrical, mechanical, connectivity, or other monitor abnormal operation, or by failure of a sensor or component. Technical alarm conditions may also be caused when an algorithm cannot classify or interpret the available data.

Apart from the physiological and technical alarms, the monitor can also prompt with some messages describing the system status or patient status.

Alarm Priorities

By severity, the alarms are classified into the following priority levels:

High priority alarms: indicate a life threatening situation or a severe device malfunction. High priority alarms require an immediate response.

Medium priority alarms: indicate abnormal vital signs or a device malfunction. Medium priority alarms require a timely response.

BeneVision N1 Patient Monitor Operator’s Manual 6 - 1

6.3.3

Low priority alarms: indicate a discomfort condition, a device malfunction, or an improper operation. Low priority alarms require you to be aware of this condition.

Messages: provides additional information on the patient or the equipment.

Alarm Indicators

When an alarm occurs, the monitor indicates it through visual or audible alarm indications. For more information, see the following table.

Alarm Indicator High Priority

Alarm

Alarm lamp

Audible tone pattern

Red

Flashing frequency: 1.4 -

2.8 Hz

Duty cycle: 20 -

60% on

ISO Repeat pattern of triple + double + triple

+ double beeps

Mode 1 Repeat pattern of high-pitched single beep

Mode 2 Repeat pattern of high-pitched triple beeps

Alarm message White text inside a red box

Medium

Priority Alarm

Yellow

Flashing frequency: 0.4 -

0.8 Hz

Duty cycle: 20 -

60% on

Repeat pattern of triple beeps

Repeat pattern of double beeps

Repeat pattern of double beeps

Black text inside a yellow box

Low Priority

Alarm

Cy a n

No flashing

Duty cycle:

100% on

Single beep

Low-pitched single beep

Low-pitched single beep

Black text inside a cyan box

Message Comments

None

None

None

None

White text

None

None

Alarm priority indicator

Parameter value

*** ** * None

Alarm messages are displayed in the alarm information area at the top of the screen. You can select the alarm messages to show the alarm list.

The indicator appears in front of the corresponding alarm message.

None White text inside a flashing red box

Black text inside a flashing yellow box

Black text inside a flashing cyan box

None

NOTE

When multiple alarms of different priority levels occur simultaneously, the monitor selects the highest priority alarm to light the alarm lamp and issue the alarm tone.

When multiple alarms of different priority levels occur simultaneously and should be displayed in the same area, the monitor only displays the messages from the highest priority alarm.

When multiple alarms of the same priority levels occur simultaneously alarm messages are displayed cyclically.

Some physiological alarms, such as Asystole, are exclusive. They have identical alarm tones and alarm lights with normal high level physiological alarms, but their alarm messages are displayed exclusively. That is, when an exclusive physiological alarm and a normal high level physiological alarm are triggered simultaneously, only exclusive physiological alarm message will be displayed.

6 - 2 BeneVision N1 Patient Monitor Operator’s Manual

6.3.4

Alarm Status Symbols

Apart from the alarm indicators as described in 6.3.3 Alarm Indicators , the monitor uses the following symbols

to indicate the alarm status:

Alarm pause: indicates that all the alarms are paused.

Alarm off: indicates that individual measurement alarms are turned off or the system is in the alarm off status.

Audio pause: indicates that audible alarm tones are paused.

Audio off: indicates that audible alarm tones are turned off.

Alarm reset: indicates that the alarm system is reset.

6.4

Accessing On-screen Help for Technical Alarms (AlarmSight)

In the technical alarm list, alarm messages followed by Detail include help messages or pictures to help you identify the problem. This function is called AlarmSight. To access AlarmSight, follow this procedure:

1.

Select an alarm displaying in the technical alarm information area to enter the Alarms dialog.

2.

From the alarm list select the desired alarm.

NOTE

If there are no displayed alarms, then selecting the technical alarm area will not open any dialogs.

6.5

6.6

6.6.1

Checking the Physiological Alarms List

If the patient monitor has more than one physiological alarm, you can see the physiological alarm list by selecting the physiological alarm information area to enter the Alarms dialog. If there is only one physiological alarm, selecting the physiological alarm information area enters the Review dialog for the event created by this alarm.

Changing Alarm Settings

Alarms settings can be changed by selecting Main Menu and choosing from the list in the Alarm column.

Setting Parameter Alarm Properties

To set parameter alarm properties, follow this procedure:

BeneVision N1 Patient Monitor Operator’s Manual 6 - 3

1.

Select the Main Menu quick key → from the Alarm column select Limits.

2.

Enter the password if required.

3.

Select a parameter tab and set alarm properties as desired.

You can also change the alarm properties of individual parameter from the corresponding parameter dialog.

6.6.2

NOTE

The monitor can be configured to require an password or login to change alarm settings. For more

information, refer to 21.13.3 Selecting Password for User Authentication

.

Changing the Alarm Volume

To change the alarm volume, follow this procedure:

1.

Select the Main Menu quick key

from the Alarm column select Setup.

2.

Set Alarm Volume . The alarm volume can be set from X to 10, in which X is the minimum volume allowed by your department, and 10 is the maximum volume.

3.

Select High Alarm Volume to set the volume of the high priority alarm.

4.

Select Reminder Volume to set the volume of the reminder tone.

NOTE

When the alarm volume is set to 0, the alarm sound is turned off and the audio off symbol appears on the screen.

You cannot set the volume of high priority alarms if Alarm Volume is set to 0.

You can set the Alarm Volume to 0 only when your monitor is connected to the CMS. If your monitor is not connected to the CMS, the lowest setting of Alarm Volume is 1.

When the monitor is connected to the CMS and Alarm Volume is set to 0, Alarm Volume automatically changes to 2 if the CMS is disconnected.

6.6.3

Setting the Auto Limits for New Patient Switch

If the Auto Limits for New Patient function is enabled, a dialog box can pop up to ask you whether to set alarm limits based on the latest parameter measurements for a newly admitted patient. To set the Auto Limits for

New Patient switch, follow this procedure:

1.

Enter the alarm setup page in any of the following ways:

Select the Alarm Setup quick key

select the Setup tab.

Select the Main Menu quick key

from the Alarm column select Setup .

2.

Set the Auto Limits for New Patient switch.

6 - 4 BeneVision N1 Patient Monitor Operator’s Manual

When Auto Limits for New Patient is switched on, the confirmation dialog box pops up if all of the following requirements are met:

Within 10 minutes after the patient is admitted.

Continuous measurements are stable.

An NIBP measurement has been taken.

HR alarm switch is on.

No lethal alarms are triggered.

The patient is not in poor perfusion condition.

Alarm limits of no parameters were manually changed.

The monitor is not in intubation mode, private mode, or CPB mode.

NOTE

The Auto Limits for New Patient function is intended for newly admitted patients only.

The automatically set alarm limits take effect only after being confirmed.

6.6.4

Initiating Auto Alarm Limits

The monitor provides the auto alarm limits function to automatically adjust alarm limits according to the patient’s vital signs. When auto limits are selected, the monitor calculates safe auto limits based on the latest measured values. To get accurate auto alarm limits, collect a set of measured vital signs as a baseline.

To initiate auto alarm limits, follow this procedure:

1.

Select the Main Menu quick key

from the Alarm column select Limits.

2.

From the Limits page, select Auto Limits at the left bottom.

3.

Select Ok from the popup dialog box.

Then the monitor will automatically calculate alarm limits based on the latest measured values. Before applying these automatically created alarm limits, confirm if they are appropriate for the patient from the Limits dialog. If not, you can adjust them manually. These alarm limits will remain unchanged until you select auto limits again or adjust them manually.

The monitor calculates auto limits based on the following rules:

Module

ECG

Resp

SpO

2

Parameter Lower Limit

HR/PR

(bpm)

RR (rpm)

SpO

2

(%)

Upper Limit Auto Limit Range

Adult/ pediatric

Neonate Adult/ pediatric

Neonate

HR × 0.8 or 40

(whichever is greater)

RR × 0.5 or 6

(whichever is greater)

Same as the default alarm limit

(HR - 30) or 90

(whichever is greater)

(RR - 10) or 30

(whichever is greater)

Same as the default alarm limit

HR × 1.25 or

240

(whichever is smaller)

(RR × 1.5) or

30 (whichever is smaller)

Same as the default alarm limit

(HR + 40) or

200

(whichever is smaller)

(RR + 25) or

85 (whichever is smaller)

Same as the default alarm limit

Adult/pediatric: 35 to 240

Neonate: 55 to 225

Adult/pediatric: 6 to 55

Neonate: 10 to 90

Same as the measurement range

BeneVision N1 Patient Monitor Operator’s Manual 6 - 5

6 - 6

Module

NIBP

Temp

(xx refers to temperat ure site)

IBP: ART/

Ao/UAP/

BAP/FAP/

LV/P1-P4

(Arterial pressure)

Txx (°C)

ΔT (°C)

IBP-S

(mmHg)

IBP-D

(mmHg

IBP: PA

IBP: CPP

IBP-S

(mmHg)

IBP-D

(mmHg

IBP-M

(mmHg)

CPP

(mmHg)

Parameter Lower Limit

NIBP-S

(mmHg)

NIBP-D

(mmHg)

NIBP-M

(mmHg)

IBP-M

(mmHg)

Upper Limit Auto Limit Range

Adult/ pediatric

(SYS × 0.68 +

10)

(Dia × 0.68 +

6)

(Mean × 0.68

+ 8)

(Txx - 0.5)

Same as the default alarm limit

Neonate

(SYS - 15) or

45 (whichever is greater)

(Dia - 15) or

20 (whichever is greater)

(Mean - 15) or

35 (whichever is greater)

(Txx - 0.5)

Same as the default alarm limit

Adult/ pediatric

(SYS × 0.86 +

38)

(Dia × 0.86 +

32)

(Mean × 0.86

+ 35)

(Txx + 0.5)

Same as the default alarm limit

Neonate

(SYS + 15) or

105

(whichever is smaller)

(Dia + 15) or

80 (whichever is smaller)

(Mean + 15 or

95)

(whichever is smaller)

(Txx + 0.5)

Same as the default alarm limit

Adult: 45 to 270

Pediatric: 45 to 185

Neonate: 35 to 115

Adult: 25 to 225

Pediatric: 25 to 150

Neonate: 20 to 90

Adult: 30 to 245

Pediatric: 30 to 180

Neonate: 25 to105

1 to 49

Same as the measurement range

SYS × 0.68 +

10

(Dia × 0.68 +

6)

Mean × 0.68 +

8

SYS × 0.75

(SYS - 15) or

45 (whichever is greater)

(Dia - 15) or

20 (whichever is greater)

(Mean - 15) or

35

(whichever is greater)

SYS × 0.75

SYS × 0.86 +

38

(Dia × 0.86 +

32)

Mean × 0.86 +

35

SYS × 1.25

(SYS + 15) or

105

(whichever is smaller)

(Dia + 15) or

80 (whichever is smaller)

(Mean + 15) or 95

(whichever is smaller)

SYS × 1.25

Adult: 45 to 270

Pediatric: 45 to 185

Neonate: 35 to 115

Adult: 25 to 225

Pediatric: 25 to 150

Neonate: 20 to 90

Adult: 30 to 245

Pediatric: 30 to180

Neonate: 25 to 105

3 to 120

Dia × 0.75

Mean × 0.75

Dia × 0.75

Mean × 0.75

CPP × 0.68 + 8 (CPP-15) or

Mean × 0.75

35,

(whichever is greater)

Mean × 0.75

Dia × 1.25

Mean × 1.25

CPP × 0.86 +

35

Mean × 1.25

Dia × 1.25

Mean × 1.25

3 to 120

3 to 120

IBP: CVP/

LAP/

RAP/

UVP/P1-

P4

(Venous pressure)

IBP-M

(mmHg)

(CPP+15) or

95,

(whichever is smaller)

Mean × 1.25

Adult: 20 to 235

Pediatric: 25 to175

Neonate: 25 to 100

3 to 40

BeneVision N1 Patient Monitor Operator’s Manual

Module

CO

2

Parameter Lower Limit

EtCO awRR

(rpm)

2

(mmHg)

FiCO

2

Upper Limit Auto Limit Range

Adult/ pediatric

0 to 32: remains the same

33 to 35: 29

Neonate

0 to 32: remains the same

33 to 35: 29

Adult/ pediatric

0 to 32: remains the same

33 to 35: 41

Neonate

0 to 32: remains the same

33 to 35: 41

Same as the measurement range

36 to 45:

(etCO

2

- 6)

46 to 48: 39

36 to 45:

(etCO

2

- 6)

46 to 48: 39

36 to 45:

(etCO

2

+ 6)

46 to 48: 51

36 to 45:

(etCO

2

+ 6)

46 to 48: 51

>48: remains the same

None

>48: remains the same

None awRR × 0.5 or

6 (whichever is greater)

(awRR - 10) or

30 (whichever is greater)

>48: remains the same

Same as the default alarm limit awRR × 1.5 or

30 (whichever is smaller)

>48: remains the same

Same as the default alarm limit

(awRR+25) or

85 rpm

(whichever is smaller)

Same as the measurement range

Same as the measurement range

Same as the measurement range

Same as the measurement range

Same as the measurement range

Adult/pediatric: 6 to 55

Neonate: 10 to 90

6.6.5

6.6.6

6.6.7

Setting the Zero RR Delay Time

To set the zero respiration rate delay time, follow this procedure:

1.

Select the Main Menu quick key

from the Alarm column select Setup.

2.

Select Zero RR Delay to set the zero respiration rate delay time.

Switching On or Off V-Tach Latching

When V-Tach Latching Lock is switched on, you can switch on or off V-Tach Latching . To do so, follow this procedure:

1.

Select the Main Menu quick key → from the Alarm column select Setup.

2.

Switching on or off V-Tach Latching .

For information on the V-Tach Latching function, see

21.3.4 Latching Physiological Alarms .

Restoring the Default Alarm Settings

To reset all alarm settings to the defaults, follow this procedure:

1.

Select the Main Menu quick key

from the Alarm column select Limits.

2.

On the Limits page, select Defaults at the bottom.

6.6.8

Setting the Length of Printed Waveforms

You can define the length of printed waveforms when an alarm is triggered. To do so, follow this procedure:

1.

Select the Main Menu quick key

from the Alarm column select Setup.

2.

Set Printing Duration On Alarm .

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6.7

Pausing Alarms/Pausing Alarm Tones

You can either pause alarms or pause alarm tones. This depends on the pause setting. To set the pause function, refer to

21.3.3 Defining the Pause Function

.

6.7.1

Pausing Alarms

If the Pause function is configured to alarm pause, pressing the Alarm Pause quick key can temporarily disable alarm indicators. For the configuration of the pause function, see

21.3.3 Defining the Pause Function

. When alarms are paused, the following rules are followed:

No physiological alarm will be presented.

For technical alarms, alarm sounds are paused, but alarm lamps and alarm messages continue to be presented.

The remaining alarm pause time is displayed in the physiological alarm information area.

The alarm pause symbol is displayed in the system information area.

When the alarm pause time expires, the alarm paused state is automatically deactivated. You can also cancel the alarm paused state by pressing the Alarm Pause quick key again.

6.7.1.1

Prolonging the Alarm Pause Time

If enabled, you can temporarily prolong the alarm pause time after the monitor enters the alarm paused state.

This capability is disabled by default. To prolong the alarm pause time, follow this procedure:

1.

In the physiological alarm information area, select the alarm pause countdown.

2.

Select Pause 5 min, Pause 10 min , or Pause 15 min .

NOTE

Prolonging alarm pause time does not affect the setting of alarm pause time.

6.7.1.2

Switching Off All Alarms

If Pause Time is set to Permanent

(see section 21.3.3.1 Setting the Alarm Pause Time/Alarm Tone Pause Time ),

pressing the Alarm Pause quick key permanently switches off all alarms. The alarm off state has the following features:

Physiological alarms are switched off. The alarm lamp does not flash and alarm sound is not issued.

Alarm sound of technical alarms is switched off, but alarm lamp flashes and alarm messages are presented.

The message Alarm Off with red background is displayed in the physiological alarm information area.

The alarm off symbol is displayed in the system status information area.

To exit the alarm off state, press the Alarm Pause quick key again.

WARNING

Pausing or switching off alarms may result in a hazard to the patient.

6.7.2

Pausing Alarm Sound

If the Pause function is configured to Audio Pause, pressing the Audio Pause quick key pauses alarm tone and sets the quick key to be highlighted. For the configuration of the pause function, see section

21.3.3 Defining the

Pause Function

. When alarm tones are paused, the following rules are followed:

The sound of all physiological alarms and technical alarms are switched off.

The remaining audio pause time is displayed in the physiological alarm information area.

The audio pause symbol is displayed in the system information area.

When the audio pause time expires, the audio paused state is automatically deactivated. You can also cancel the audio paused state by pressing the highlighted Audio Pause quick key again.

6 - 8 BeneVision N1 Patient Monitor Operator’s Manual

6.7.2.1

Prolonging the Alarm Tone Pause Time

If enabled, you can temporarily prolong the alarm tone pause time after the monitor enters the alarm tone paused state. This capability is disable by default. To prolong the audio pause time, follow this procedure:

1.

In the physiological alarm information area, select the alarm pause countdown.

2.

Select the alarm tone pause time. Options may include Pause 5 min, Pause 10 min , or Pause 15 min .

NOTE

Prolonging alarm pause time does not affect the setting of alarm tone pause time.

6.7.2.2

Switching Off Alarm Sound

If Pause Time is set to Permanent

(see section 21.3.3.1 Setting the Alarm Pause Time/Alarm Tone Pause Time

), pressing the Audio Pause quick key permanently switches off all alarm sound. The audio off state has the following features:

Alarm sound of both physiological alarms and technical alarms is switched off.

The audio off symbol is displayed in the system information area.

To exit the audio off state, press the Audio Pause quick key again.

WARNING

Pausing or switching off alarm sound may result in a hazard to the patient.

6.8

Resetting Alarms

Press the Alarm Reset quick key to reset the alarm system. When the alarm system is reset, the alarm reset symbol displays in the system status information area for alarm symbols.

NOTE

If a new alarm is triggered after the alarm system is reset, the alarm reset icon will disappear and the alarm light and alarm tone will be reactivated.

6.8.1

6.8.2

6.9

Resetting Physiological Alarms

For physiological alarms, when the alarm system is reset, the following occur:

The alarm sound is silenced.

A √ appears before the alarm message.

The color of the parameter numeric background corresponds with the alarm priority, but the parameter numeric does not flash.

Resetting Technical Alarms

For technical alarms, when the alarm system is reset, the following occur:

Some technical alarms are cleared. The monitor gives no alarm indications.

Some technical alarms are changed to prompt messages.

For some technical alarms, the alarm is silenced and a √ appears before the alarm message.

For details about the indications of technical alarms when the alarm system is reset, see D.2 Technical Alarm

Messages

.

Latching Alarms

The latching setting for physiological alarms defines how alarm indicators behave if you do not reset the alarms.

■ If you do not “latch” physiological alarms, their alarm indications disappear when the alarm condition ends.

BeneVision N1 Patient Monitor Operator’s Manual 6 - 9

■ If you “latch” physiological alarms, all visual and audible alarm indications remain (if configured) until the alarms are reset. For latched alarms the time when the alarm is last triggered is displayed behind the alarm message.

The monitor can be set to separately latch visual indications or simultaneously latch the visual and the audible indications.

When visual indications are latched, visual indications, including alarm lamp, alarm message and its background remain when the alarm condition ends and the time when the alarm last triggered is displayed behind the alarm message.

When audible indications are latched, the monitor continues to issues alarm sounds when the alarm condition ends.

To set how you want to latch the physiological alarms, see section 21.3.4 Latching Physiological Alarms .

NOTE

Changing alarm priority may affect the latching status of the corresponding alarm. Determine if you need to adjust the latching status for the specific alarm when you have changed its alarm priority.

When the alarm system is reset, latched physiological alarms are cleared.

6.10

CPB Mode

The CPB (Cardiopulmonary Bypass) mode is activated only if you set the department to OR .

In the CPB mode, all the physiological alarms and technical alarms are switched off. So when performing CPB, you can put the monitor in the CPB mode to inactivate unnecessary alarms.

6.10.1

Entering the CPB Mode

To enter the CPB mode, select the Main Menu quick key

from the Alarm column select CPB Mode .

In the CPB mode, CPB Mode is displayed in the physiological alarm area with a red background color.

NOTE

When the CPB mode is entered, the monitor stops all NIBP measurements. You can restart NIBP measurements after entering the CPB mode.

6.10.2

Exiting the CPB Mode

To exit the CPB mode, select the Main Menu quick key

from the Alarm column select Exit CPB Mode .

6.11

Intubation Mode

Intubation mode is available for Resp and CO

2

monitoring. When performing intubation during general anesthesia, you can put the monitor in the intubation mode in order to inactivate unnecessary alarms.

In the intubation mode, Resp and CO

2

related physiological alarms are switched off.

6.11.1

Entering the Intubation Mode

To enter the intubation mode, choose either of the following ways:

From the bottom of the Resp or CO2 dialog, select Intubation Mode .

Select the Main Menu quick key

→ from the Alarm column select Intubation Mode .

6.11.2

Exiting the Intubation Mode

To exit the intubation mode, choose either of the following ways:

From the bottom of the Resp or CO2 dialog, select Exit Intubation Mode .

Select the Main Menu quick key from the Alarm column

→ select Exit Intubation Mode .

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6.12

Testing Alarms

The monitor automatically performs a selftest at startup. Check that an alarm tone is heard, the alarm lamp illuminates, one after the other, in red, yellow, and cyan. This indicates that the visible and audible alarm indicators function correctly.

To further test individual measurement alarms, perform measurements on yourself or using a simulator. Adjust alarm limits and check that appropriate alarm behavior is observed.

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6 - 14 BeneVision N1 Patient Monitor Operator’s Manual

7

Monitoring ECG, Arrhythmia, ST and QT

7.1

ECG Introduction

The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the monitor as waveforms and numerics. ECG monitoring provides 3-, 5-, 6-, and 12-lead ECG monitoring, ST-segment analysis, arrhythmia analysis, QT/QTc measurements, and optional 12-lead resting analysis via the Glasgow algorithm.

The N1 monitor incorporating ST analysis has the ST label.

The N1 monitor incorporating 12-lead has the 12-lead label.

(1)

(2)

(3)

7.2

(1) 12-lead label (2) ST label (3) Glasgow label

ECG Safety Information

WARNING

This equipment is not intended for direct cardiac application.

Ensure that the conductive parts of ECG electrodes and associated connectors, including the neutral electrode, do not come into contact with any other conductive parts including earth.

Always use defibrillation-proof ECG cables during defibrillation.

Do not touch the patient, or metal devices connected to the patient, during defibrillation.

To minimize the hazard of burns during high-frequency surgical procedures, ensure that the monitor’s cables and transducers never come into contact with the electrosurgery unit (ESU).

To minimize the hazard of burns during use of high-frequency surgical unit (ESU), the ECG electrodes should not be located between the surgical site and the ESU return electrode.

CAUTION

Only use parts and accessories specified in this manual. Follow the instructions for use and adhere to all warnings and cautions.

Periodically inspect the electrode application sites to ensure skin integrity. If the skin quality changes, replace the electrodes or change the application site.

BeneVision N1 Patient Monitor Operator’s Manual 7 - 1

7.3

Interference from an ungrounded instrument near the patient or electrosurgery usage can induce noise and artifact into the waveforms.

ECG Display

The following figures show the ECG waveform and numeric areas. The display may be configured to look slightly different.

(1) (2) (3) (4) (5) (6)

(7)

(1) ECG lead label of the displayed waveform

(3) ECG filter mode

(2) ECG waveform gain

(4) Notch filter status

is displayed. If Paced is set to No , (5) Paced status: If Paced is set to Yes ,

(6) HR/PR alarm message

is displayed.

(7) Pace pulse marker: If Paced is set to Yes , pace pulse markers “|” are displayed corresponding to detected pacer for each beat.

(1)

(2)

(4)

7.4

7.4.1

7.4.2

(3)

(1) Parameter label

(3) HR alarm limits

(2) HR measurement unit

(4) HR value

Preparing for ECG Monitoring

Preparing the Patient Skin

Proper skin preparation is necessary to ensure good signal quality at the electrode sites, as the skin is a poor conductor of electricity. To properly prepare the skin, choose flat areas and then follow this procedure:

1.

Shave hair from skin at chosen electrode sites.

2.

Gently rub skin surface at sites to remove dead skin cells.

3.

Thoroughly cleanse the site with a mild soap and water solution. We do not recommend using ether or pure alcohol, because this dries the skin and increases the resistance.

4.

Dry the skin completely before applying electrodes.

Applying Electrodes and Connecting the Patient

To connect ECG cables, follow this procedure:

7 - 2 BeneVision N1 Patient Monitor Operator’s Manual

1.

Check that electrode packages are intact and the electrodes are not past the expiry date. Ensure the electrode gel is moist. If you are using snap electrodes, attach the snaps to the electrodes before placing electrodes on the patient.

2.

Place the electrodes on the prepared sites. Ensure that all electrodes have good skin contact.

3.

Connect the leadwires to the patient cable if not already connected.

4.

Plug the patient cable into the ECG connector.

CAUTION

Never mix patient electrode types or brands. This may lead to impedance mismatches issues.

NOTE

When applying the electrodes, avoid bony area, obvious layers of fat, and major muscles. Muscle movement can result in electrical interference. Applying electrodes on major muscles, for example on muscles of the thorax, may lead to erroneous arrhythmia alarms due to excessive muscle movement.

7.4.3

Lead Wire Color Code

The following table lists the color coding of leadwires for AHA standards:

Lead

Right arm

Left arm

Right leg (neutral)

Left leg

Chest 1

Chest 2

Chest 3

Chest 4

Chest 5

Chest 6

Label

V1

V2

V3

V4

RA

LA

RL

LL

V5

V6

Color

White

Black

Green

Red

Brown/Red

Brown/Yellow

Brown/Green

Brown/Blue

Brown/Orange

Brown/Violet

7.4.4

ECG Electrode Placements

In this section, electrode placement is illustrated using the AHA naming convention.

7.4.4.1

3-leadwire Electrode Placement

The following is the electrode configuration when a 3-leadwire cable is used:

RA placement: directly below the clavicle and near the right shoulder.

LA placement: directly below the clavicle and near the left shoulder.

LL placement: on the left lower abdomen.

RA LA

LL

BeneVision N1 Patient Monitor Operator’s Manual 7 - 3

7.4.4.2

5-leadwire and 6-leadwire Electrode Placement

The following is the electrode configuration for a 5-leadwires cables:

RA placement: directly below the clavicle and near the right shoulder.

LA placement: directly below the clavicle and near the left shoulder.

RL placement: on the right lower abdomen.

LL placement: on the left lower abdomen.

V placement: on the chest in any of the V1 to V6 positions.

For 6-leadwire placement, you can use the position for the 5 leadwire placement but with two chest leads. The two chest leads (Va and Vb) can be positioned at any two of the V1 to V6 positions. For more information, see

7.4.4.3 Chest Electrode Placement

. The Va and

Vb lead positions are configurable. For more information, see

7.5.3.3 Changing Va and Vb Labels

.

V

RL

RA LA

7.4.4.3

Chest Electrode Placement

The chest electrode can be placed at the following positions:

V1 placement: on the fourth intercostal space to the right of the sternum.

V2 placement: on the fourth intercostal space to the left of the sternum.

V3 placement: midway between the V2 and V4 electrode positions.

V4 placement: on the fifth intercostal space at the left midclavicular line.

V5 placement: on the left anterior axillary line, horizontal with the V4 electrode position.

V1

VE V2 V3

V6 placement: on the left midaxillary line, horizontal with the V4 electrode position.

V3R-V6R placement: on the right side of the chest in positions corresponding to those on the left.

V6

V5

V4

NOTE

For the 5-leadwire and 6-leadwire placement, place the precordial electrode according to the physician's preference.

LL

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7.4.4.4

10-leadwire Electrode Placement

12-lead ECG uses 10 electrodes, which are placed on the patient’s four limbs and chest. The limb electrodes should be placed on the limb extremities and the chest electrodes placed according to the physician’s preference. The figure at right illustrates the conventional 10-leadwire electrode placement.

7.4.4.5

Lead Placement for Pacemaker Patients

The recommended lead placement for monitoring a pacemaker patient is as follows.

RA

Pacemaker

LA

LL

RA

V1

RL

Pacemaker

LA

LL

3-leadwire Electrode Placement 5-leadwire Electrode Placement

A pacemaker patient usually requires a different electrode patch placement configuration than a nonpacemaker patient.

Do not place an ECG electrode directly over the pacemaker generator. Place the electrode patches 2 to 3 inches away from the pacemaker generator area. For example, if the pacemaker generator is located in the left subclavian area, relocate the Left Arm electrode closer in towards the center of the chest.

7.4.4.6

Lead Placement for Surgical Patients

The surgical site should be taken into consideration when placing electrodes on a surgical patient. For example, for open-chest surgery, the chest electrodes can be placed on the lateral chest or back. To reduce artifacts and interference from electrosurgical units, you can place the limb electrodes close to the shoulders and lower abdomen and the chest electrodes on the left side of the mid-chest. Do not place the electrodes on the upper arm. Otherwise, the ECG waveform will be very small.

WARNING

To reduce the hazard of burns during use of electrosurgical units (ESU), the ECG electrodes should not be located between the surgical site and the ESU return electrode.

Never entangle the ESU cable and the ECG cable together.

BeneVision N1 Patient Monitor Operator’s Manual 7 - 5

When using ESU, never place ECG electrodes near the grounding plate of the ESU, as this can cause a lot of interference on the ECG signal.

When using ESU, ensure proper contact of the ESU return electrode to the patient to avoid burns at monitor measurement sites. Also ensure that the ESU return electrode is near the operating area.

7.4.5

7.4.6

Choosing the ECG Lead Type

To choose ECG lead type, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Setup tab.

3.

Set Lead Set according to the lead type you are going to use. The default lead type is Auto . In this case, the monitor automatically detects the lead type.

Checking Paced Status

It is important to correctly set the patient’s paced status before you start monitoring ECG. The paced symbol is displayed when Paced is set to Yes . Pace pulse markers “|” are displayed on each ECG waveform whenever a pacer signal is detected. If Paced is set to No or unspecified, the symbol will be shown in the ECG waveform area.

To change the paced status, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Pacer tab.

3.

Set Paced to Yes or No .

You can also change the patient’s paced status from the Patient Management dialog. For more information, see

5.2.1 Entering the Patient Management Dialog

.

If you did not set the paced status, the monitor issues a prompt tone when pace pulse is detected. At the same time, the paced symbol flashes and the message Please check if the patient has a pacemaker?

appears in the ECG waveform area. Check and set the patient’s paced status.

WARNING

For paced patients, you must set Paced to Yes. If it is incorrectly set to No, the monitor could mistake a pace pulse for a QRS complex and fail to alarm when the ECG signal is too weak. On ventricular paced patients, episodes of ventricular tachycardia may not always be detected. Do not rely entirely upon the system’s automated arrhythmia detection algorithm.

False low heart rate or false asystole alarms may result with certain pacemakers because of pacemaker artifacts, such as electrical overshoot of the pacemaker overlapping the true QRS complexes.

Do not rely entirely on rate meter alarms when monitoring patients with pacemakers. Always keep these patients under close surveillance.

The auto pacer recognition function is not applicable to pediatric patients and neonatal patients.

7.4.7

Enabling Pacer Rejection

To eliminate the pacing pulse from the ECG waveform of paced patients, it is recommended to enable the pace pulse rejection function. The pace pulse rejection function is disabled by default. To enable this function, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Pacer tab.

3.

Switch on Pacer Reject .

7 - 6 BeneVision N1 Patient Monitor Operator’s Manual

NOTE

When pace pulses are detected, the pace pulse markers “|” are shown on the ECG waveforms. Pacer

Rejection setting has no impact on the display of pace pulse markers “|”.

You can switch on pacer rejection only when Paced is set to Yes. If Paced is set to no, the Pacer Reject function is disabled.

7.5

Changing ECG Settings

7.5.1

7.5.2

Choosing an ECG Screen

When monitoring ECG, several display options are available.

For 3-lead ECG monitoring, only normal screen is available.

For 5-lead ECG monitoring, besides the normal screen, you can also choose Full-screen (7-lead).

For 6-lead ECG monitoring, besides the normal screen, you can also choose Full-screen (8-lead).

For 12-lead ECG monitoring, besides the normal screen, you can also choose Full-screen (7-lead), or 12-

Lead (12-lead analysis).

To choose the desired screen configuration, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select Full-Screen or 12-Lead .

To return to the normal screen, press the highlighted button to unselect that screen.

Alternately you can choose the desired screen configuration as follows:

1.

Select the Screen Setup quick key

Choose Screen or select the Main Menu quick key

→ from the

Display column select Choose Screen .

2.

Select ECG Full-Screen or ECG 12-Lead .

Setting ECG Alarm Properties

To select the desired ECG alarm options, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Alarm tab.

3.

Select the desired alarm options.

7.5.3

Changing ECG Wave Settings

7.5.3.1

Selecting the Leads of Displayed ECG Waveforms

To select the desired ECG waveforms to be displayed, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Setup tab.

3.

Select ECG to set the lead of each displayed ECG waveform.

4.

If more than three ECG waveforms are to be displayed, select the More Leads tab, and then select ECG to set leads of other ECG waveforms.

For optimal ECG analysis, select leads with the following characteristics:

The QRS complex should be either completely above or below the baseline and it should not be biphasic.

The QRS complex should be tall and narrow.

The P waves and T waves should be less than 0.2mV.

BeneVision N1 Patient Monitor Operator’s Manual 7 - 7

CAUTION

Ensure that you have selected the optimal leads with the best waveform amplitude and the highest signal-to-noise ratio. Selecting the optimal leads is important for detecting beats, classifying beats, and detecting ventricular fibrillation.

7.5.3.2

Changing ECG Waveform Size

If the ECG waveform is too small or clipped, you can change its size by selecting the appropriate Gain setting. To do so, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Setup tab.

3.

Select ECG Gain to set the size of each ECG waveform.

4.

If more than three ECG waveforms are displayed, select the More Leads tab, and then select ECG Gain to change the sizes of other ECG waveforms. If you select Auto , the monitor automatically adjusts the size of the ECG waveforms for all the leads.

7.5.3.3

Changing Va and Vb Labels

When monitoring ECG with 6-leadwire. You can change the labels of Va and Vb leads. To do so, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Setup tab.

3.

Set Va and Vb according to the locations of the Va and Vb electrode sites. Default settings are Va and Vb .

7.5.3.4

Changing ECG Waveform Speed

To change ECG waveform speed, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Setup tab.

3.

Set the desired Speed .

7.5.3.5

Setting the ECG Filter

To set the appropriate ECG waveform filter mode, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Setup tab.

3.

Set Filter .

◆ Diagnostic : use when diagnostic quality ECG is required. The unfiltered ECG waveform is displayed so that changes such as R-wave notching or discrete elevation or depression of the ST segment are visible.

◆ Monitor : use under normal monitoring conditions.

◆ Surgery : use when the signal is distorted by high frequency or low frequency interference. High frequency interference usually results in large amplitude spikes making the ECG signal look irregular.

Low frequency interference usually leads to wandering or rough baseline. The surgery filter reduces artifacts and interference from electrosurgical units. Under normal measurement conditions, selecting Surgery may suppress certain features or details of the QRS complexes.

◆ ST : recommended for ST monitoring.

7.5.3.6

Switching On or Off the Notch Filter

The notch filter removes the line frequency interference. To switch on or off the notch filter, follow this procedure:

7 - 8 BeneVision N1 Patient Monitor Operator’s Manual

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Setup tab.

3.

Switch on or off Notch Filter .

NOTE

The notch filter can only be switched on or off when ECG Filter is set to Diagnostic. In other filter modes, the notch filter is always on.

7.5.4

7.5.5

7.5.6

Disabling the Smart Lead Off Function

The monitor provides the smart lead off function. When the lead corresponding to the first ECG wave gets detached but another lead is available, the monitor automatically switches to the available lead to recalculate heart rate, and to analyze and detect arrhythmias. When you reconnect the detached leads, the monitor automatically switches back to the original lead.

The smart lead off function is enabled by default. To disable this function, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Setup tab.

3.

Switch off Smart Lead .

Adjusting the QRS Volume

To adjust the QRS volume, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Setup tab.

3.

Set QRS Volume .

When valid SpO

2

measurements are available, the monitor adjusts the pitch of QRS tone based on the SpO

2 value.

Adjusting the Minimum QRS Detection Threshold

To avoid false asystole alarm due to low R wave amplitude, and to avoid tall T waves and P waves being mistaken for QRS complexes, the monitor provides a means to manually adjust the minimum QRS detection threshold.

To adjust the minimum QRS detection threshold, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Setup tab and set Filter to Monitor .

3.

Select the QRS Threshold tab.

4.

Select up or down arrow buttons to adjust the minimum threshold for QRS detection. Selecting Default resets the QRS threshold to the default value (0.16 mV).

CAUTION

The setting of the QRS detection threshold can affect the sensitivity for arrhythmia, ST, QT/QTc detection, and heart rate calculation.

If the QRS amplitude is low, the monitor might not be able to detect the beats and false asystole calls may occur.

NOTE

The minimum QRS detection threshold can only be adjusted when the ECG filter is set to Monitor.

BeneVision N1 Patient Monitor Operator’s Manual 7 - 9

7.6

7.6.1

Monitoring Arrhythmia

Arrhythmia monitoring is intended for adult and pediatric patients.

Arrhythmia Safety Information

WARNING

Heart rate reading may be affected by cardiac arrhythmias. Do not rely entirely on heart rate alarms when monitoring patients with arrhythmias. Always keep these patients under close surveillance.

The arrhythmia analysis program may incorrectly identify the presence or absence of an arrhythmia.

Therefore, a physician must analyze the arrhythmia information with other clinical findings.

Atrial fibrillation (Afib) detection function is not intended for pediatric and neonatal patients.

CAUTION

Since the arrhythmia detection algorithm sensitivity and specificity are less than 100%, it is possible for false arrhythmias to be detected and true arrhythmia events to not be detected. The possibility increases when the signal is noisy.

The ECG size and minimum QRS detection threshold settings affect arrhythmia detection and heart rate calculation sensitivity.

If QRS amplitude is low, the monitor might be unable to calculate heart rate and thus create false asystole calls. During the learning phase of the algorithm, arrhythmia detection may not be available. It is recommended to closely monitor patient condition during, and for several minutes after, the learning phase to allow the algorithm to reach optimal detection performance.

7.6.2

Arrhythmia Events

This section lists all arrhythmia events and their criteria.

7.6.2.1

Lethal Arrhythmia Events

Arrhythmia message Description

Asystole

V-Fib/V-Tach

V-Tach

No QRS complex detected within the set time interval in the absence of ventricular fibrillation or chaotic signal.

A fibrillatory wave for 6 consecutive seconds.

A dominant rhythm of adjacent PVCs and the ventricular rate is greater than the V-tach rate limit.

The number of consecutive PVCs is greater than or equal to the V-Tach PVCs limit, and the ventricular rate is greater than or equal to the V-Tach rate limit.

7.6.2.2

Nonlethal Arrhythmia Events

Arrhythmia message

Vent Brady

Extreme Tachy

Extreme Brady

R on T

Run PVCs

Couplet

Description

The number of consecutive PVCs is greater than or equal to V brady PVC limit and the ventricular rate is less than the V-Brady Rate limit.

The heart rate is greater than the extreme tachycardia limit.

The heart rate is less than the extreme bradycardia limit.

R on T PVC is detected.

More than two consecutive PVCs, but lower than the V-Brady PVCs limit, and the ventricular rate is lower than the V-Tach rate limit.

A Pair of PVCs detected in between normal beats.

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7.6.3

Arrhythmia message

Multiform PVC

PVC

Bigeminy

Trigeminy

Tachy

Brady

Pacer Not Capture

Pacer Not Pacing

Missed Beat

Nonsus V-Tach

Vent Rhythm

Pause

Irr Rhythm

A-Fib (for adult only)

PVCs/min

Pauses/min

Irr Rhythm End

A-Fib End (for adult only)

*N: normal beat; V: ventricular beat

Description

Multiform PVCs detected in Multif. PVC's Window (which is adjustable).

One PVC detected in between normal beats.

A dominant rhythm of N, V, N, V, N, V * .

A dominant rhythm of N, N, V,N, N, V, N, N, V * .

The heart rate is greater than the tachycardia limit.

The heart rate is lower than the bradycardia limit.

No QRS complex detected for 300 ms following a pace pulse (for paced patients only).

No pace pulse detected for 1.75 x average R-to-R intervals following a QRS complex (for paced patients only).

At least 3 consecutive Ns * , and

The current RR interval is greater than 1.5 x previous RR interval, and

The next RR interval is lower than 1.5 x average RR interval, and

HR lower than 100 and the current RR interval is greater than 1.75 x average RR interval , or

HR is greater than or equal to 100 and the current RR interval is greater than 1000 ms.

The number of consecutive PVCs is lower than the V-Tach PVCs limit but greater than 2, and the ventricular rate is greater than or equal to the V-Tach Rate limit.

The number of consecutive PVCs is greater than or equal to the V-Brady PVCs limit, and ventricular rate is greater than or equal to the V-Brady Rate limit but lower than V-Tach Rate limit.

No QRS complex is detected within the set pause time threshold.

Consistently irregular rhythm (N * , irregular RR interval change is greater than 12.5%)

P wave is absent and normal beat RR intervals are irregular.

PVCs/min exceeds high limit.

Pauses/min exceeds high limit.

Irregular rhythm no longer detected for the irregular rhythm end delay time.

Atrial fibrillation no longer detected for the A-Fib end delay time.

Displaying Arrhythmia Information

You can display the arrhythmia information in the numeric area. To do so, follow this procedure:

1.

Access Tile Layout using either of the following ways:

◆ Select the Screen Setup quick key → select the Tile Layout tab.

◆ Select Main Menu quick key → from the Display column select Tile Layout .

2.

Click the numeric area where you want to display the arrhythmia information, and then select ECG →

Arrhythmia .

7.6.4

Changing Arrhythmia Settings

7.6.4.1

Changing Arrhythmia Alarm Settings

To set the arrhythmia alarm properties, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Arrhythmia tab

Alarm tab.

3.

Set alarm properties as desired.

BeneVision N1 Patient Monitor Operator’s Manual 7 - 11

NOTE

You can switch off lethal arrhythmia alarms only when the monitor is set to enableLethal Arrh

Alarms Off. For more information, see 21.3.9.1 Setting the Lethal Arrhythmia Alarms Switch

.

The priority of lethal arrhythmia alarms is always high. It cannot be altered.

7.6.4.2

Changing Arrhythmia Alarm Threshold Settings

You can change threshold settings for certain arrhythmia alarms. When an arrhythmia exceeds its threshold, an alarm will be triggered. To do so, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Arrhythmia tab

select the Threshold tab.

3.

Enter the password if required. For more information, refer to 21.13.3 Selecting Password for User

Authentication

.

4.

Set the threshold for the desired arrhythmia alarms.

NOTE

The asystole delay time relates to ECG relearning. When heart rate is less than 30 bpm, it is recommended to set Asystole Delay to 10 sec.

7.6.4.3

Arrhythmia Threshold Range

Arrhythmia

Asystole Delay

Tachy (HR High)

Brady (HR Low)

Extreme Tachy

Extreme Brady

Multif PVCs Window

V-Tach Rate

V-Brady Rate

V-Tach PVCs

V-Brady PVCs

PVCs/min

Pauses/min

Pause Threshold

AF/Irr Rhy End Time

Threshold Range

3 sec to 10 sec

60 bpm to 295 bpm

16 bpm to 120 bpm

65 bpm to 300 bpm

15 bpm to 115 bpm

3 beats to 31 beats

100 bpm to 200 bpm

15 bpm to 60 bpm

3 beats to 99 beats

3 beats to 99 beats

1 to 100

1 to 15

1.5 sec, 2.0 sec, 2.5 sec, 3.0 sec

0 min, 1 min, 2 min, 3 min, 4 min, 5 min, 10 min, 15 min, 30 min

7.6.4.4

Setting Thresholds for PVC-Related Alarms

PVC-related alarms are detected on the basis of the current PVC rate and the number of consecutive PVCs.

To set the required thresholds for PVC-related alarms, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Arrhythmia tab → select the More Threshold tab.

7 - 12 BeneVision N1 Patient Monitor Operator’s Manual

3.

Enter the password if required. For more information, refer to 21.13.3 Selecting Password for User

Authentication

.

Adjust V-Tach PVCs , V-Tach Rate , V-Brady PVCs , and V-Brady Rate as necessary to set the thresholds for the desired PVC-related alarms.

The following figure illustrates the conditions under which PVC alarms will be generated if V-Tach PVCs is set to

6, V-Tach Rate is set to 130, V-Brady PVCs is set to 5, and V-Brady Rate is set to 40.

7.6.5

If the number of consecutive PVCs is greater than or equal to the V-Tach PVCs limit (6), and the ventricular rate (Vent Rate) is greater than or equal to the V-Tach Rate limit (130), a V-Tach alarm is generated.

If the number of consecutive PVCs is lower than the V-Tach PVCs limit (6) but greater than 2, and the ventricular rate is greater than or equal to the V-Tach Rate limit (130), a Nonsus V-Tach alarm is generated.

If the number of consecutive PVCs is greater than or equal to the V-Brady PVCs limit (5), and the ventricular rate is lower than the V-Tach Rate limit (130) but greater than or equal to the V Brady Rate limit (40), a Vent

Rhythm alarm is generated.

If the number of consecutive PVCs is lower than the V-Brady PVCs limit (5) but greater than 2, and the ventricular rate is lower than the V-Tach Rate limit (130), a Run PVCs alarm is generated.

If the number of consecutive PVCs is greater than or equal to the V-Brady PVCs limit (5), and the ventricular rate is lower than the V Brady Rate limit (40), a Vent Brady alarm is generated.

Intelligent Arrhythmia Alarm

Normally, an arrhythmia alarm is presented when an alarm condition is detected. However, there are certain situations that can inhibit audible and visible alarm indications even though an alarm condition was detected.

For more information, see 7.6.5.1 Arrhythmia Alarm Chains and 7.6.5.2 Arrhythmia Alarm Shielding Rules .

BeneVision N1 Patient Monitor Operator’s Manual 7 - 13

7.6.5.1

Arrhythmia Alarm Chains

If multiple alarms overlap, announcing all of the detected alarm conditions would be confusing, and a more serious condition might be overlooked. So arrhythmia alarms are prioritized by alarm "chains".

Asystole

V Ͳ Fib/V Ͳ Tach

V Ͳ Tach / Vent Brady

PVC Alarm Chain

Nonsus V Ͳ Tach /

Vent Rhythm

Run PVCs

Extreme Tachy/

Extreme Brady

Beat Detection

Alarm Chain

Pauses/min

Rate Alarm Chain

Tachy/Brady

Pause

HR High /

HR Low

Couplet

Pacer not Capture /

Pacer not Pacing /

Missed Beat

R on T

A Ͳ Fib Alarm Chain

A Ͳ Fib/

A Ͳ Fib End

Irr. Rhythm/

Irr.Rhythm End

Bigeminy

Trigeminy

PVCs/min

Multiform PVC

PVC

7.6.5.2

Arrhythmia Alarm Shielding Rules

The following table explains how audible and visual alarms are indicated during arrhythmia alarm shielding period .

Previous alarm

Alarm in high priority chain

Alarm in medium priority chain

Current alarm

Alarm in high priority chain

Alarm in medium priority chain

Alarm indication

Alarm light and alarm tone

During the shielding period, alarm light and alarm tone are disabled. When the shielding period is reached, alarm light and alarm tone are reactivated.

Alarm light and alarm tone

Alarm light and alarm tone

Alarm in high priority chain

Alarm in the same medium priority chain, but with higher priority

The same alarm reoccurs

Alarm in the same medium priority chain, but with lower priority

Alarm in other medium priority chain

During the shielding period, alarm light and alarm tone are disabled. When the shielding period is reached, alarm light and alarm tone are reactivated.

During the shielding period, alarm light and alarm tone are disabled. When the shielding period is reached, alarm light and alarm tone are reactivated.

Alarm light and alarm tone

7 - 14 BeneVision N1 Patient Monitor Operator’s Manual

7.6.5.3

Arrhythmia Alarm Refractory Period

For the following eight alarms in medium priority chain, there is a 30-second refractory period. That is to say, if the same alarm is not presented within 30 seconds after the previous alarm disappears.

Couplet

R on T

PVCs/min High

Multiform PVCs

PVC

Missed Beat

Pacer not Capture

Pacer not Pacing

7.7

ST Segment Monitoring

ST segment analysis is intended for adult, pediatric and neonatal patients. To use this feature, the N1 must be labeled to support ST analysis, see

7.1 ECG Introduction .

7.7.1

ST Safety Information

WARNING

ST segment deviation values may be affected by such factors as certain drugs or metabolic and conduction disturbances.

ST deviation is often calculated at a fixed offset from the J point. Changes in heart rate may affect ST.

The significance of ST segment changes needs to be determined by a physician.

This monitor provides information regarding changes in ST deviation levels. The clinical significance of the ST level change information should be determined by a physician.

7.7.2

7.7.3

Enabling ST Monitoring

The ST monitoring function is disabled by default. Before you start ST monitoring, enable the ST function. To do so, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the ST tab → select the Setup tab.

3.

Switch on ST Analysis .

Reliable ST monitoring cannot be ensured under the following situations:

You are unable to get a lead that is not noisy.

Arrhythmias, such as atrial fibrillation or atrial flutter, which may cause an irregular baseline.

The patient is continuously ventricularly paced.

The patient has left bundle branch block.

In these cases, you may consider switching off ST monitoring.

Displaying ST Deviation Numerics

To display ST numerics, follow this procedure:

1.

Access Tile Layout by either of the following ways:

◆ Select the Screen Setup quick key → select the Tile Layout tab.

◆ Select Main Menu quick key → from the Display column select Tile Layout .

2.

Click the numeric area where you want to display the ST numerics, and then select ECG → ST .

BeneVision N1 Patient Monitor Operator’s Manual 7 - 15

The ST parameter display area is configured differently according to the ECG cable used:

When you are using the 3-lead ECG leadwires, a separate ST numeric area does not appear on the display.

The ST deviation value displays in the ECG numeric area.

When you are using the 5-lead ECG leadwires, the ST numeric area displays 7 ST deviation values: ST-I, ST-II,

ST-III, ST-aVR, ST-aVL, ST-aVF, ST-V.

When you are using the 6-lead ECG leadwires, the ST numeric area displays 8 ST deviation values: ST-I, ST-II,

ST-III, ST-aVR, ST-aVL, ST-aVF, ST-Va, ST-Vb.

When you are using the 12-lead ECG leadwires, the ST numeric area displays12 ST deviation values: ST-I, ST-

II, ST-III, ST-aVR, ST-aVL, ST-aVF, ST-V1, ST-V2, ST-V3, ST-V4, ST-V5, ST-V6.

This example shows the ST numeric area when 5-lead ECG cable is used. The monitor screen may look slightly different:

(4) (5)

(1)

(2)

(3 )

7.7.4

(1) Parameter label

(3) ST alarm off symbol

(2) ST measurement unit

(4) Lead labels

(5) ST numerics: a positive value indicates ST segment elevation, and a negative value indicates ST segment depression.

Displaying ST Segments in the Waveform Area

You can display ST segments in the waveform area. To do so, follow this procedure:

1.

Access Tile Layout by either of the following ways:

◆ Select the Screen Setup quick key → select the Tile Layout tab.

◆ Select Main Menu quick key → from the Display column select Tile Layout .

2.

Select the waveform area where you want to display the ST segments, and then select ECG → ST .

7 - 16 BeneVision N1 Patient Monitor Operator’s Manual

ST segment shows a QRS complex segment for each measured ST lead. The current ST segment is drawn in the same color as the ECG wave, usually green, superimposed over the stored reference segment, drawn in a different color. The information is updated once every ten seconds.

(1) (2)

(3 )

7.7.5

7.7.6

(1) ST lead

(3) Baseline ST deviation value

(4) (5)

(2) Current ST deviation value

(4) 1 mV scale

(5) Current ST segment (green) and baseline ST segment (white)

Entering the ST View

In ST View mode a complete QRS segment for each ST lead is displayed. The color of the current ST segments and ST deviation values is consistent with the color of the ECG waveforms, normally green. The color of the baseline ST segments and ST deviation values is white.

To enter the ST View, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the ST tab.

3.

From the bottom of the dialog, select ST View .

Saving the Current ST Deviation and Segment as Baseline

ST deviation is typically monitored as a relative change from a baseline value. Set an ST baseline when ST deviation values become stable. If you did not set the ST baseline, the monitor automatically saves the baseline when valid ST deviation values appear for 5 minutes. To set the ST baseline, follow this procedure:

1.

From the ST View , select Set Baseline .

2.

From the pop-up dialog box, select Ok to set the current ST segments and values as the baseline.

From the ST View , you can also perform the following operations:

Display or hide ST baseline by selecting Display Baseline or Hide Baseline

Display or hide the position of ISO point, J point and ST point by selecting

.

Display Marker or Hide Marker .

CAUTION

Updating ST baseline affects ST alarms.

BeneVision N1 Patient Monitor Operator’s Manual 7 - 17

7.7.7

Entering the ST Graphic (only available when the N1 is used with the independent external display)

To display ST Graphic , follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the ST tab.

3.

Select ST Graphic .

The following figure shows the ST Graphic when ST Alarm Mode is set to Absolute . The height of the bar indicates the ST deviation value of corresponding ST lead. The color of the bar indicates ST alarm status: green indicates that corresponding ST deviation value is within alarm limits; cyan, yellow and red indicate that the ST deviation value exceeds the alarm limits. The color matches ST alarm priority.

The following figure shows the ST Graphic when ST Alarm Mode is set to Relative . The height of grey bar indicates the baseline ST deviation value and the green bar (cyan, yellow or red if an alarm occurs) indicates relative ST from that baseline.

7.7.8

Changing ST Settings

7.7.8.1

Setting ST Alarm Properties

To set ST alarm properties, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the ST tab → Alarm tab.

3.

Set ST Alarm Mode to Absolute or Relative .

◆ Absolute : you can separately set the alarm properties for each ST alarm for each lead.

◆ Relative : you can set the alarm properties for ST Single and ST Dual alarms.

4.

Set ST alarm properties.

7 - 18 BeneVision N1 Patient Monitor Operator’s Manual

7.7.8.2

Changing Leads for ST Display

The monitor automatically selects the three most deviated leads for ST display. You can also manually select the leads. To do so, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the ST tab → select the Setup tab.

3.

Set ST Segment . You can select up to 3 leads.

7.7.8.3

Showing ISO Point, J Point, and ST Point Markers

In the waveform area, the ISO point, J point, and ST point marker do not display on the ST segments by default.

To display these markers, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the ST tab

select the Setup tab.

3.

Switch on Show Markers .

7.7.9

Adjusting ST Measurement Points

7.7.9.1

About ST Point, ISO Point, and J Point

The ST deviation value for each beat is the potential difference between the isoelectric (ISO) point and the ST point. The ISO point provides the baseline. The ST point is located between the J point and the start of the Twave. The J point is the end of the QRS complex. As the ST point is at a fixed distance away from the J point (40,

60, 80 etc msec), manually adjusting the J point helps you correctly position the ST point.

R

P

(1) (2) (3) T (4)

Q

(1) ISO point (2) J point

S

(3) ST point (4) ST deviation

7.7.9.2

Setting ST Point, ISO Point, and J Point

CAUTION

If Auto Adjust is Off, or if the patient's heart rate or ECG morphology changes significantly, the ISO and ST points need to be occasionally adjusted because this may affect the QT interval and thus the location of the ST point. False ST segment depression or elevation may occur if the isoelectric point or the ST point is incorrectly set.

Always ensure that the locations of ST points are appropriate for the patient.

To set the ST point, ISO point, and J point, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the ST tab → select the Adjust tab.

3.

Set ST Point .

The setting for Auto Adjust defines the method of adjusting the ISO and J point locations. Auto Adjust is enabled by default. In this case, the locations of the ISO point and J point are automatically determined by the

BeneVision N1 Patient Monitor Operator’s Manual 7 - 19

7.8

7.8.1

7.8.2

algorithm. When Auto Adjust is disabled, you need to manually adjust the position of the ISO point and J point using the arrows at the right sides of ISO and J .

The ISO point (isoelectric) location shown is relative to the R-wave peak. Position the ISO point in the middle of the flattest part of the waveform (between the P and Q waves).

The J point location is indicated relative to the R-wave peak. Position the J point at the end of the QRS complex and the beginning of the ST segment.

The ST point is positioned a fixed distance from the J point. Position the ST point relative to the J point at

J+60/80ms , J+40ms , J+60ms or J+80ms . When J+60/80ms is selected, the ST point will be positioned 80 ms (heart rate 120 bpm or less) or 60 ms (heart rate more than 120 bpm) from the J point.

QT/QTc Interval Monitoring

The QT interval is the time between the beginning of the Q-wave and the end of the T-wave. It represents the total duration of the depolarization (QRS duration) and repolarization (ST-T) phases of the ventricles. QT interval monitoring can assist in the detection of long QT syndrome.

The QT interval has an inverse relationship to heart rate. Faster heart rates shorten QT interval and slower heart rates prolong QT interval. Therefore, several formulas are commonly used to correct the QT interval for heart rate. The heart rate corrected QT interval is abbreviated as QTc.

QT/QTc interval monitoring is intended for adult, pediatric, and neonatal patients.

QT/QTc Monitoring Limitations

Some conditions may make it difficult to achieve reliable QT/QTc monitoring, for example:

R-wave amplitudes are too low

The presence of frequent ventricular ectopic beats

RR intervals are unstable

P-waves tending to encroach on the end of the previous T-wave at high heart rates

The T-wave is very flat or T-wave are not well defined

The end of the T-wave is difficult to delineate because of the presence of U-waves

QTc measurements are not stable

In the presence of noise, asystole, ventricular fibrillation, atrial fibrillation, or ECG lead off

For reliable QT/QTc monitoring, choose lead with good T-wave amplitude and no visible flutter activity, and without a predominant U-wave or P-wave.

Some conditions such as left or right bundle branch block or ventricular hypertrophy can lead to a widened QRS complex. If a long QTc is observed you should verify it to ensure that it is not caused by QRS widening.

Because normal beats followed by ventricular beats are not included in the analysis, no QT measurement will be generated in the presence of a bigeminy rhythm.

If the heart rate is extremely high (over 150 bpm for adults and over 180 bpm for pediatrics and neonates), QT will not be measured. When the heart rate changes, it can take several minutes for the QT interval to stabilize. For reliable QTc calculation it is important to avoid measurements when the heart rate is changing.

Enabling QT/QTc Monitoring

The QT monitoring function is disabled by default. Before you start QT monitoring, enable the QT function. To do so, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the QT tab → select the Setup tab.

3.

Switch on QT Analysis .

7 - 20 BeneVision N1 Patient Monitor Operator’s Manual

7.8.3

7.8.4

Displaying QT Numerics and Segments

To display QT numerics and Segments, follow this procedure:

1.

Access Tile Layout by either of the following ways:

◆ Select the Screen Setup quick key

select the Tile Layout tab.

Select Main Menu quick key

→ from the Display column select Tile Layout .

2.

Click the parameter numeric area where you want to display the QT numerics, and then select ECG

QT/

QTc .

NOTE

QTc values are calculated based on the QT-HR, not the ECG HR. To view the QT-HR, open the QT View.

For more information, see

7.8.4 Entering the QT View .

The following picture shows the QT numeric area. The monitor screen may look slightly different:

(3)

(2)

(4)

(5)

(1 )

(6)

(1) QTc alarm limit (if QTc alarm is off, the alarm off symbol is displayed)

(2) Parameter label (3) QTc value

(4) ΔQTc value (the difference between the current and baseline QTc values)

(5) QT value (6) QT-HR value

Entering

the

QT View

QT View shows the current and baseline QT parameter values and waveforms. To enter QT View, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the QT tab.

3.

Select QT View .

The following picture shows a typical QT view.

The current waveform is shown in the upper half in green.

The baseline waveform is shown below in white.

BeneVision N1 Patient Monitor Operator’s Manual 7 - 21

7.8.5

■ The waveform of selected lead is highlighted, while the waveforms of other leads are in light green or light gray.

The start of the QRS complex and the end of the T wave are marked with a vertical line.

In some conditions, no QT measurement can be made. Then the cause of failed QT measurement is shown at the bottom of the QT numerics area and the message “Cannot Analyze QT” is shown in the technical alarm area.

Select the left or right arrow to switch leads, and the corresponding waveform will be highlighted.

Saving the Current QTc as Baseline

In order to quantify changes in the QTc value, you can set a QTc baseline. If no baseline has been set for this patient within the first five minutes after getting valid QT values, the monitor will automatically set a baseline. To set the current values as baseline, follow this procedure:

1.

From the QT View , select Set Baseline .

2.

From the pop-up dialog box, select Ok . This baseline will then be used to calculate ΔQTc.

If you set a new baseline the previous baseline is discarded.

From the QT View , you can also perform the following operations:

■ Select the left or right arrow to select a lead label to highlight corresponding waveform.

■ Select Display Baseline or Hide Baseline to display or hide the baseline waveform.

CAUTION

Updating QTc baseline affects the ΔQTc value and alarm.

7.8.6

Changing QT Settings

7.8.6.1

Setting QT Alarm Properties

To set QT alarm properties, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the QT tab

select the Alarm tab.

3.

Set QTc and ΔQTc alarm properties.

7.8.6.2

Selecting Leads for QT Calculation

You can select one lead or all leads for QT calculation. To do so, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the QT tab → select the Setup tab.

3.

Set QT Leads . All is selected by default. This means all leads are used for QT calculation.

7.9

7.9.1

ECG Relearning

Changes in ECG beat morphology could result in incorrect arrhythmia alarms and/or inaccurate heart rate. ECG relearning allows the monitor to learn the new dominant beat morphology and thus reduce false arrhythmia alarms and inaccurate HR values. Once learning is complete, the dominant QRS complex is stored as a reference template. The reference template is used as the normal morphology of that patient and it is compared with incoming beats to identify possible arrhythmias.

Auto ECG Relearning

Auto arrhythmia relearning happens in the following situation:

■ The ECG lead type or lead label is changed.

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7.9.2

ECG leads are off and are not reconnected within 60 seconds.

The patient‘s paced status is changed.

Initiating an ECG Relearning Manually

If you suspect that false arrhythmia alarms are presented, you may need to manually initiate an ECG relearn. To do so, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select Relearn .

CAUTION

Initiate ECG relearning only during periods of predominantly normal rhythm and when the ECG signal is relatively noise-free. If ECG learning takes place during arrhythmias, the ectopic beats may be incorrectly learned as normal QRS complexes. This may result in missed detection of subsequent arrhythmia events.

7.10

Defibrillation Synchronization Pulse Output

The 12-lead N1 monitor provides an analog out connector to output synchronization pulses for defibrillators. If a defibrillator is connected, it receives a synchronization pulse (100 ms, +5 V) through the multifunction connector each time an R-wave is detected. The 3/5/6 lead N1 monitor does not offer this output.

WARNING

According to IEC 60601-2-4: 2010, the peak of the synchronized defibrillator discharge should be delivered within 60 ms of the peak of the R wave. The signal at the ECG output (sync pulse) on the monitor is delayed by maximum of 30 ms. the biomedical engineer should verify that the ECG/

Defibrillator combination does not exceed recommended maximum delay of 60 ms.

Before defibrillation, ensure that both defibrillator and monitor have passed the system test and can be safely used together.

7.11

ECG Troubleshooting

This section lists some of the problems that might be encountered during ECG monitoring. If you encounter problems when using the monitor or accessories, check the table below before requesting for services. If the problem persists after you have taken corrective actions, contact the service personnel.

NOTE

For the physiological and technical alarm messages, see

D Alarm Messages

.

Problem

Noisy ECG traces

Excessive electrosurgical Interference

Muscle Noise

Corrective Actions

1. Check that the electrodes are not detached or dry. Replace with fresh and moist electrodes if necessary.

2. Check that leadwires are not defective. Replace leadwires if necessary.

3. Check that the patient cable or leadwires are not routed too close to other electrical devices. Move the patient cable or leadwires away from electrical devices and their cables if necessary.

Use ESU-proof ECG cables.

For more information, see

25.1 ECG Accessories .

Inadequate skin preparation, tremors, tense subject, and/or poor electrode placement.

1. Perform skin preparation again and re-place the electrodes. For more

information, see 7.4.1 Preparing the Patient Skin and 7.4.2 Applying Electrodes and Connecting the Patient

.

2. Apply fresh, moist electrodes. Avoid muscular areas.

BeneVision N1 Patient Monitor Operator’s Manual 7 - 23

Problem

Intermittent Signal

Excessive alarms: heart rate, lead fault

Low Amplitude ECG Signal

No ECG Waveform

Base Line Wander

Corrective Actions

1. Check that cables are properly connected.

2. Check that electrodes are not detached or dry. Perform skin preparation again as described in

7.4.1 Preparing the Patient Skin

and apply fresh and moist electrodes.

3. Check that the patient cable or leadwires are not damaged. Change them if necessary.

1. Check that electrodes are not dry. Perform skin preparation again and re-place the electrodes. For more information, see

7.4.1 Preparing the

Patient Skin and 7.4.2 Applying Electrodes and Connecting the Patient

.

2. Check for excessive patient movement or muscle tremor. Reposition the electrodes. Replace with fresh and moist electrodes if necessary.

1. Check that the ECG gain is not set too low. Adjust the gain as required.

For more information, see 7.5.3.2 Changing ECG Waveform Size .

2. Perform skin preparation again and re-place the electrodes. For more information, see

7.4.1 Preparing the Patient Skin

and

7.4.2 Applying

Electrodes and Connecting the Patient

.

3. Check electrode application sites. Avoid bone or muscular area.

4. Check that electrodes are not dry or used for a prolonged time. Replace with fresh and moist electrodes if necessary.

1. Check that the ECG gain is not set too low. Adjust the gain as required.

For more information, see 7.5.3 Changing ECG Wave Settings .

2. Check that the leadwires and patient cables are properly connected.

3. Change cable and lead wires if necessary.

4. Check that the patient cable or leadwires are not damaged. Change them if necessary.

1. Check for excessive patient movement or muscle tremor. Secure leadwires and cable.

2. Check that electrodes are not detached or dry and replace with fresh and

moist electrodes if necessary. For more information, see 7.4.1 Preparing the Patient Skin and 7.4.2 Applying Electrodes and Connecting the Patient

.

3. Check for ECG filter setting. Set ECG Filter mode to Monitor to reduce baseline wander on the display.

7 - 24 BeneVision N1 Patient Monitor Operator’s Manual

8

Resting 12-Lead ECG Analysis

8.1

8.2

Resting 12-Lead ECG Analysis Introduction

The monitor can be configured with the Glasgow 12-lead resting ECG analysis algorithm. The monitor incorporating the Glasgow algorithm is labeled with the logo of Glasgow as shown in 7.1 ECG Introduction .

The Glasgow algorithm is intended for adult, pediatric, and neonatal patients.

Entering the 12-Lead Screen

To enter the 12-Lead screen, follow this procedure:

1.

Select the ECG numeric area or waveform area to enter the ECG dialog.

2.

From the bottom of the ECG dialog, select 12-Lead .

You can also enter the 12-Lead screen by following this procedure:

Select the Screen Setup quick key

select the Choose Screen tab

select ECG 12-Lead .

Select Main Menu quick key

→ from the Display column select Choose Screen

select ECG 12-Lead .

NOTE

The ECG 12-Lead screen is available only when the Glasgow algorithm is configured (associated module has the Glasgow label) and Lead Set is set to Auto or 12-Lead.

8.3

8.4

8.4.1

8.4.2

Initiating Resting 12-Lead ECG Analysis

Before initiating 12-lead ECG analysis, check that all electrodes are correctly connected to the lead wires and the

ECG trunk cable is properly connected. Check that patient information is correct. Keep the patient still.

To initiate 12-Lead ECG analysis, select Analyze from the bottom left of the 12-Lead screen.

Changing 12-Lead ECG Analysis Settings

On the ECG 12-Lead screen, you can set the high frequency filter, baseline drift removal (BDR) filter, and the waveform layout.

Setting the High Frequency Filter

The high frequency filter attenuates muscle artifact by restricting the included frequencies. The setting of the high frequency filter is 35 Hz by default. To change the setting, follow this procedure:

1.

On the ECG 12-Lead screen, select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Setup tab.

3.

Set High-Freq Cut-off .

The high frequency filter is a low-pass filter. That is to say, signal frequencies higher than the set frequency are filtered out. For example, if you set High-freq Cutoff to 35 Hz , then signal below 35 Hz is kept in the signal and signal exceeding 35 Hz is attenuated.

Setting the Baseline Drift Removal Filter

The baseline drift removal (BDR) filter suppresses most baseline drift interference and also is able to preserve the fidelity of the ST-segment level. BDR is switched on by default. To set the BDR, follow this procedure:

1.

On the ECG 12-Lead screen, select the ECG numeric area or waveform area to enter the ECG dialog.

BeneVision N1 Patient Monitor Operator’s Manual 8 - 1

2.

Select the Setup tab.

3.

Switch on or off Baseline Drift Removal as desired. If BDR is switched off, the 0.05 Hz high pass filter is used.

NOTE

BDR introduces around 1-second delay. Using BDR is recommended except when the delay is unacceptable.

8.4.3

8.4.4

Setting the 12-Lead Waveform Layout

To set the 12-lead waveform layout, follow this procedure:

1.

On the ECG 12-Lead screen, select the ECG numeric area or waveform area to enter the ECG dialog.

2.

Select the Setup tab.

3.

Set Waveform Layout .

◆ Standard : the waveform sequence is I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6.

◆ Cabrera : the waveform sequence is aVL, I, -aVR, II, aVF, III, V1, V2, V3, V4, V5, V6.

For the Glasgow algorithm, the sequence of the chest leads depends on the setting of V3 Placement . If V3 placement is set to V4R , the sequence of chest leads is V4R, V1, V2, V4, V5, V6.

Editing Patient Information

Some patient information may directly affect ECG analysis. Complete and correct patient information is helpful for accurate diagnosis and treatment of the patient. Enter patient information before starting a resting ECG analysis.

To enter patient information, follow this procedure:

1.

On the ECG 12-Lead screen, select Setup to enter the 12-Lead Setup dialog.

2.

On the Patient Demographics page, input or edit patient information.

NOTE

Saving information will also save the information as though it was entered in the Patient

Management dialog.

Changes are not saved until you press Save. So changing to another tab without saving and then pressing the exit button “X” will lose any changes.

Check that patient information is correct before starting a resting 12-lead analysis.

Using pediatric lead placement V4R, V1, V2, V4 - V6 is recommended if the patient is under 16 years of age. Please record V4R using the V3 electrode. Also set V3 Electrode to V4R. This is a normal practice for a patient of this age.

8.4.5

Setting Tachycardia and Bradycardia Thresholds

To set tachycardia and bradycardia thresholds, follow this procedure:

1.

On the ECG 12-Lead screen, select Setup to enter the 12-Lead Setup dialog.

2.

Select the Setup tab.

3.

Set Tachy and Brady .

NOTE

The tachycardia threshold only applies to patients whose age exceeds 180 days.

The bradycardia threshold only applies to patients whose age exceeds 2191 days (6 years).

8 - 2 BeneVision N1 Patient Monitor Operator’s Manual

8.4.6

8.5

8.6

8.7

Setting the 12-Lead Interpretation Report

To set the 12-lead interpretation report, follow this procedure:

1.

On the ECG 12-Lead screen, select Setup to enter the 12-Lead Setup dialog.

2.

Select the Report tab.

3.

Set the format and items included in the 12-lead interpretation report.

Saving the 12-Lead Interpretation Report

At the completion of 12-lead ECG interpretation, select Save to save the report. You can review the saved 12-

lead interpretation reports. For more information, see 15.2.10 12-Lead ECG Review Page .

Printing the 12-Lead Interpretation Report

At the completion of 12-lead ECG interpretation, select Print to output the report via the printer.

Exiting the ECG 12-Lead Screen

To exit the ECG 12-Lead screen, select Exit on the ECG 12-Lead screen.

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8 - 4 BeneVision N1 Patient Monitor Operator’s Manual

9

Monitoring Impedance Respiration (Resp)

9.1

9.2

Resp Introduction

Impedance respiration is measured across the thorax. When the patient is breathing or ventilated, the volume of air changes in the lungs, resulting in impedance changes between the electrodes. Impedance respiration rate

(RR) is calculated from the signal representing these impedance changes, and a respiration waveform is displayed on the patient monitor screen.

Impedance respiration monitoring is intended for adult, pediatric and neonatal patients.

Respiration may also be measured using a CO

2

module. Refer to 14 Monitoring Carbon Dioxide (CO

2)

for respiration information specific to the CO

2

module.

Impedance Resp Safety Information

WARNING

When monitoring the patient’s impedance respiration, do not use ESU-proof ECG cables. The monitor cannot measure impedance respiration with ESU-proof ECG cables.

If you do not set the detection level for the respiration correctly in manual detection mode, it may not be possible for the monitor to detect zero respiration rate. If you set the detection level too low, the monitor is more likely to detect cardiac activity, and to falsely interpret cardiac activity as respiratory activity in case of zero respiration rate.

The respiration measurement does not recognize the cause of zero respiration rates. It only indicates an alarm if a pre-adjusted time has elapsed without a breath being detected since the last detected breath. Therefore, it cannot be used for diagnostic purpose.

If operating under conditions according to the EMC Standard IEC 60601-1-2 (Radiated Immunity 3V/ m), field strengths above 3V/m may cause erroneous measurements at various frequencies.

Therefore, it is recommended to avoid the use of electrically radiating equipment in close proximity to the impedance respiration measurement unit.

The current used to measure impedance respiration may cause rate changes in Minute Ventilation

Rate Responsive Pacemakers. If you suspect the patient monitor is affecting the pacemaker rate then replace the ECG cable with an ECG cable that contains ESU filters.

CAUTION

Only use parts and accessories specified in this manual.

Impedance respiration monitoring is not for use on patients while they are active, as this can cause false alarms.

BeneVision N1 Patient Monitor Operator’s Manual 9 - 1

9.3

Resp Display

(1) (2) (3) (4) (5)

(1) Resp waveform gain

(4) Respiration rate (RR)

(2) Resp lead label

(5) RR source

(3) Alarm limits

NOTE

If ESU-proof ECG cables are used, the Resp waveform area will display the message “Check Leads”.

Replace the ECG cable if necessary.

9.4

9.4.1

Preparing for Impedance Resp Monitoring

Preparing the Patient

Follow this procedure to prepare the patient:

1.

Shave hair from skin at chosen sites.

2.

Gently rub skin surface at sites to remove dead skin cells.

3.

Thoroughly cleanse the site with a mild soap and water solution.

4.

Dry the skin completely before applying the electrodes.

CAUTION

Proper skin preparation is necessary for good signal quality at the electrode site, as the skin is a poor conductor of electricity.

9 - 2 BeneVision N1 Patient Monitor Operator’s Manual

9.4.2

Placing the Electrodes

Impedance respiration is acquired using standard ECG electrodes and cables. Either lead I (RA-LA) or lead II (RA-

LL) can be used.

For more information, see 7.4.4 ECG Electrode Placements .

(1) (2)

(1) Lead I (2) Lead II

CAUTION

Correct electrode placement can help to reduce interference from cardiac related impedance changes: avoid including the liver area and the ventricles of the heart between the respiratory electrodes. This is particularly important for neonates.

Some patients with restricted movements breathe mainly abdominally. In these cases, you may need to place the left leg electrode on the left abdomen at the point of maximum abdominal expansion to optimize the respiratory waveform.

Some patients (especially neonates) expand their chests laterally, causing a negative intrathoracic pressure. In these cases, it is better to place the two respiration electrodes in the right midaxillary and the left lateral chest areas at the patient’s maximum point of the breathing movement to optimize the impedance respiration waveform.

To optimize the impedance respiration waveform, place the RA and LA electrodes horizontally when monitoring respiration with ECG Lead I; place the RA and LL electrodes diagonally when monitoring respiration with ECG Lead II.

Periodically inspect electrode application sites to ensure skin integrity. If the skin quality changes, replace the electrodes or change the application site.

NOTE

Store the electrodes at room temperature. Open the electrode package immediately prior to use.

Check that the electrode packages are intact and that the electrodes are not past the expiration date. Ensure the electrode gel is moist.

BeneVision N1 Patient Monitor Operator’s Manual 9 - 3

9.5

9.5.1

9.5.2

9.5.3

9.5.4

9.5.5

Changing Resp Settings

Setting the Resp Alarm Properties

To set the Resp alarm properties, follow this procedure:

1.

Select the Resp numeric area or waveform area to enter the Resp dialog.

2.

Select the Alarm tab.

3.

Enter the password if required. For more information, refer to

21.13.3 Selecting Password for User Authentication .

4.

Set alarm properties as desired.

Setting the RR Source

To set RR source, follow this procedure:

1.

Select the Resp numeric area or waveform area to enter the Resp dialog.

2.

Select the Setup tab.

3.

Choose RR Source from the dropdown list.

When you select Auto , the monitor automatically selects the RR source following order of priority: first CO2 , and then ECG . When the manually selected RR source is not available, the monitor automatically switches the RR

Source to Auto .

Choosing the Respiration Lead

To set the respiration lead, follow this procedure:

1.

Select the Resp numeric area or waveform area to enter the Resp dialog.

2.

Select the Setup tab.

3.

Set Resp Lead .

If you cannot get an acceptable impedance Resp waveform or you suspect the veracity of the Resp value after choosing the Resp lead, you may need to adjust the electrode placement.

Setting the Resp Waveform Size

To set the Resp waveform size, follow this procedure:

1.

Select the Resp numeric area or waveform area to enter the Resp dialog.

2.

Select the Setup tab.

3.

Set Gain .

Setting the Resp Waveform Speed

To set the Resp waveform speed, follow this procedure:

1.

Select the Resp numeric area or waveform area to enter the Resp dialog.

2.

Select the Setup tab.

3.

Set Speed .

9 - 4 BeneVision N1 Patient Monitor Operator’s Manual

9.5.6

9.5.7

Setting the Auto Detection Switch

To set the auto detection switch, follow this procedure:

1.

Select the Resp numeric area or waveform area to enter the Resp dialog.

2.

Select the Setup tab.

3.

Switch on or off Auto Threshold Detection .

◆ If Auto Threshold Detection is switched on, the monitor automatically adjusts the Resp waveform detection level, or threshold.

◆ If Auto Threshold Detection is switched off, you have to manually adjust the Resp waveform threshold. For more information, see

9.5.7 Adjusting the Resp Waveform Detection Threshold

.

In the auto threshold detection mode, if you are monitoring Resp and the ECG parameter is switched off, the monitor cannot compare the heart rate and Resp rates to detect cardiovascular artifact. The respiration detection level is automatically set higher to prevent the detection of cardiovascular artifact as respiration.

In the manual detection mode (where auto threshold detection is off ), cardiovascular artifact can, in certain situations, trigger the respiration rate counter. This may lead to a false indication of a high respiration or an undetected zero respiration rate condition. If you suspect that cardiovascular artifact is being registered as respiratory activity, raise the detection level above the zone of cardiovascular artifact. If the Resp wave is so small that raising the detection level is not possible, you may need to optimize the electrode placement.

Adjusting the Resp Waveform Detection Threshold

Use the manual detection mode (where auto threshold detection is off ) in the following situations:

The respiration rate and the heart rate are close.

Patients have intermittent mandatory ventilation.

Respiration is weak. Try repositioning the electrodes to improve the signal.

To set the Resp waveform threshold to the desired level, follow this procedure:

1.

Select the Resp numeric area or waveform area to enter the Resp dialog.

2.

Select the Threshold tab.

3.

Select the up and down arrows below Upper Line and Lower Line to define the Resp waveform threshold.

Once set, the detection level will not adapt automatically to different respiration depths. It is important to remember that if the depth of breathing changes, you may need to change the detection level.

BeneVision N1 Patient Monitor Operator’s Manual 9 - 5

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9 - 6 BeneVision N1 Patient Monitor Operator’s Manual

10

Monitoring Pulse Oxygen Saturation (SpO

2

)

10.1

SpO

2

Introduction

Pulse Oxygen Saturation (SpO

2

) monitoring is a non-invasive technique used to measure the amount of oxygenated hemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the emitter side of the probe is partly absorbed when it passes through the monitored tissue. The amount of transmitted light is detected in the detector side of the probe. When the pulsative part of the light signal is examined, the amount of light absorbed by the hemoglobin is measured and the pulse oxygen saturation can be calculated. This device is calibrated to display functional oxygen saturation.

SpO

2

monitoring is intended for adult, pediatric and neonatal patients.

The monitor can be configured with Masimo SpO

2 or Nellcor SpO

2

:

Masimo SpO

2

: the connector is purple and the logo of Masimo SET is on the monitor.

Nellcor SpO

2

: the connector is grey and the logo of Nellcor is on the monitor.

NOTE

The SpO

2

extension cable used must be compatible with the SpO

2 sensor connectors used. For example, only the Masimo SpO

2

extension cable can be connected to the Masimo SpO

2

sensor connectors.

Measurement accuracy verification: The SpO

2

accuracy has been verified in human experiments by comparing with arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurement are statistically distributed and about two-thirds of the measurements are expected to come within the specified accuracy range compared to CO-oximeter measurements.

A functional tester or SpO

A functional tester or SpO

2

simulator can be used to determine the pulse rate accuracy.

2

simulator cannot be used to assess the SpO

2

accuracy.

BeneVision N1 Patient Monitor Operator’s Manual 10 - 1

10.2

SpO

2

Safety Information

WARNING

When a trend toward patient deoxygenation is indicated, analyze the blood samples with a laboratory co-oximeter to completely understand the patient’s condition.

Do not use SpO

2

sensors during magnetic resonance imaging (MRI). Induced current could potentially causes burns. The sensor may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements.

Prolonged continuous monitoring may increase the risk of undesirable changes in skin characteristics, such as irritation, reddening, blistering or burns. Inspect the sensor site every two hours and move the sensor if the skin quality changes. Change the application site every four hours.

For neonates, or patients with poor peripheral blood circulation or sensitive skin, inspect the sensor site more frequently.

If the sensor is too tight because the application site is too large or becomes too large due to edema, excessive pressure for prolonged periods may result in venous congestion distal from the application site, leading to interstitial edema and tissue ischemia.

When patients are undergoing photodynamic therapy they may be sensitive to light sources. Pulse oximetry may be used only under careful clinical supervision for short time periods to minimize interference with photodynamic therapy.

Setting alarm limits to extreme values may cause the alarm system to become ineffective. For example, high oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a consideration, do not set the high alarm limit to 100%, which is equivalent to switching off the alarm.

SpO

2

is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin

(COHb) and methemoglobin (MetHb).

To protect from electric shock, always remove the sensor before bathing the patient.

The pulse oximetry function of the bedside monitor should not be used for apnea monitoring.

The pulse oximetry function of the bedside monitor should not be used for arrhythmia analysis.

CAUTION

Change the application site or replace the sensor and/or patient cable when a persistent SpO2 Low

Signal Quality message is displayed on the equipment. These messages may indicate that patient monitoring time is exhausted on the patient cable or sensor.

Replace the cable or sensor when a “SpO2 Sensor Off”, “SpO2 No Sensor”, or “SpO2 Low Signal

Quality” message is consistently displayed while monitoring consecutive patients after completing troubleshooting steps listed in this manual.

Variation in measurements may be profound and may be affected by sampling technique as well as the patient's physiological conditions. Any results exhibiting inconsistency with the patient’s clinical status should be repeated and/or supplemented with additional test data. Blood samples should be analyzed by laboratory instruments prior to clinical decision making to completely understand the patient’s condition.

Use only SpO

2

sensors specified in this manual. Follow the SpO

2

sensor’s instructions for use and adhere to all warnings and cautions.

Do not place the patient monitor where the controls can be changed by the patient.

If using pulse oximetry during full body irradiation, keep the sensor out of the radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or the device might read zero for the duration of the active irradiation period.

NOTE

Additional information specific to the Masimo sensors compatible with the equipment, including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's directions for use (DFU).

10 - 2 BeneVision N1 Patient Monitor Operator’s Manual

Masimo cables and sensors are provided with X-Cal™ technology to minimize the risk of inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor DFU for the specified duration of the patient monitoring time.

10.3

SpO

2

Measurement Limitations

The following factors may influence the accuracy of SpO

2

measurement:

■ Patient physiological characteristics:

◆ Cardiac arrest

◆ Hypotension

◆ Darkly pigmented skin

◆ Shock

◆ Severe vasoconstriction

◆ Hypothermia

◆ Severe anemia

◆ Ventricular septal defects (VSDs)

◆ Venous pulsations

◆ Poor perfusion

◆ Dysfunctional hemoglobin, such as carboxyhemoglobin (COHb) and methemoglobin (MetHb)

◆ Elevated levels of bilirubin

◆ Vasospastic disease, such as Raynaud’s, and peripheral vascular disease

◆ Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc.

◆ Hypocapnic or hypercapnic conditions

◆ Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal fingers. etc.

Interfering substances:

◆ Intravascular dyes (such as indocyanine green, methylene blue, indigo carmine, etc.)

Dyes in the measure site, such as nail polish

Environmental conditions:

◆ Excessive ambient light

Electrosurgery equipment

◆ Defibrillation (may cause inaccurate reading for a short amount of time)

◆ Excessive patient/sensor motion

Electromagnetic field

◆ Arterial catheters and intra-aortic balloon

Others

Inappropriate positioning of the SpO

2

sensor, or use of incorrect SpO

2

sensor

◆ Cuff or arterial blood pressure measurement device on the same limb as the SpO

2

sensor

10.4

SpO

2

Display

(4)

(5)

(1) (2) (3)

BeneVision N1 Patient Monitor Operator’s Manual 10 - 3

(1) Pleth waveform (Pleth): visual indication of patient’s pulse. The waveform is not normalized.

(2) Oxygen saturation of arterial blood (SpO

2

): percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin.

(3) Perfusion indicator: the pulsatile portion of the measured signal caused by arterial pulsation.

(4)

(5)

Perfusion index (PI): gives the numerical value for the pulsatile portion of the measured signal caused by arterial pulsation. PI is an indicator of the pulsatile strength. You can also use it to assess the SpO

2

signal strength.

Pulse rate (derived from the pleth wave): detected pulsations per minute.

NOTE

PI is displayed for Masimo SpO

2

.

10.5

Preparing for SpO

2

Monitoring

To prepare to monitor SpO

2

, follow this procedure:

1.

Select an appropriate sensor according to the module type, patient category and weight.

2.

Clean the contact surface of the reusable sensor.

3.

Remove colored nail polish from the application site.

4.

Apply the sensor to the patient according to the instruction for use of the sensor.

5.

Select an appropriate extension cable according to the connector type and plug the cable into the SpO

2 connector.

6.

Connect the sensor to the extension cable.

CAUTION

Do not apply sensor too tightly as this results in venous pulsation which may severely obstruct circulation and lead to inaccurate measurements.

At elevated ambient temperatures, be careful with measurement sites that are not well perfused, because this can cause burns after prolonged application.

Avoid placing the sensor on extremities with an arterial catheter, an NIBP cuff or an intravascular venous infusion line.

For neonatal patients, make sure that all sensor connectors and adapter cable connectors are outside the incubator. The humid atmosphere inside can cause inaccurate measurements.

10.6

Changing the SpO

2

Settings

NOTE

The settings of in the SpO

2

module and SpO

2 b module are linked.

10.6.1

Changing the SpO

2

Alarm Settings

To change the SpO

2

alarm settings, follow this procedure:

1.

Select the SpO

2

numeric area or waveform area to enter the SpO2 dialog.

2.

Select the Alarm tab.

3.

Enter the password if required. For more information, refer to 21.13.3 Selecting Password for User

Authentication

.

4.

Set the alarm properties as desired.

10 - 4 BeneVision N1 Patient Monitor Operator’s Manual

NOTE

The desat alarm is a high level alarm notifying you of potentially life threatening drops in oxygen saturation. When the SpO

2

value is below the desat alarm limit and desat alarm switch is set on, the message “SpO2 Desat” is displayed.

You can switch off the SpO

2

Desat alarm only when the SpO

2

Desat Alarm Off is enabled. For more information, see section

21.3.6.6 Setting the Switch of the SpO

2 Desat Alarm Off

.

10.6.2

Nellcor SatSeconds

TM

Alarm Management

With traditional alarm management, high and low alarm limits are set for monitoring oxygen saturation. During monitoring, once an alarm limit is violated, an audible alarm immediately sounds. When the patient SpO

2 fluctuates near an alarm limit, the alarm sounds each time the limit is violated. Such frequent alarms can be distracting. Nellcor’s SatSeconds alarm management technique is used to reduce these nuisance alarms.

The SatSeconds feature is available with the Nellcor SpO

2

to decrease the likelihood of false alarms caused by motion artifacts. With SatSeconds alarm management, high and low alarm limits are set in the same way as those with traditional alarm management. A SatSeconds limit is also set. The SatSeconds limit controls the amount of time that SpO

2

saturation may be outside the set limits before an alarm sounds.

The method of calculation is as follows: the percentage points of the SpO

2

saturation falling outside the alarm limit is multiplied by the number of seconds remaining outside the limit. This can be stated as the equation:

SatSeconds = Points × Seconds

Only when the SatSeconds limit is reached, the monitor gives a SatSeconds alarm. For example, the figure below demonstrates the alarm response time with a SatSeconds limit set at 50 and a low SpO

2

limit set at 90%. In this example, the patient SpO

2

drops to 88% (2 points) and remains there for 2 seconds. Then it drops to 86% (4 points) for 3 seconds, and then to 84% (6 points) for 6 seconds. The resulting SatSeconds are:

% SpO

2

Total SatSeconds=

Seconds

2=

3=

6=

SatSeconds

4

12

36

52

After approximately 11 seconds, a Sat-Second alarm would sound, because the limit of 50 SatSeconds would have been exceeded.

%SpO

2

BeneVision N1 Patient Monitor Operator’s Manual

Seconds

10 - 5

Saturation levels may fluctuate rather than remaining steady for a period of several seconds. Often, the patient

SpO

2

may fluctuate above and below an alarm limit, re-entering the non-alarm range several times. During such fluctuation, the monitor integrates the number of SpO

2

points, both positive and negative, until either the

SatSeconds limit is reached, or the patient SpO

2

re-enters the non-alarm range and remains there.

NOTE

The SpO

2

Too Low or SpO

2

Too High alarm is presented in the case that SpO

2

value violates the alarm limits 3 times within one minute even if the setting of SatSeconds is not reached.

To set the SatSeconds, follow this procedure:

1.

Select the SpO

2

numeric area or waveform area to enter the SpO2 dialog.

2.

Select the Alarm tab.

3.

Set Sat-Seconds .

10.6.3

Setting SpO

2

Sensitivity (for Masimo SpO

2

)

For Masimo SpO

2

, selects the Sensitivity as per signal quality and patient motion.

Normal sensitivity is the recommended for patients who are experiencing some compromise in blood flow or perfusion. It is advisable for care areas where patients are observed frequently, such as the intensive care unit

(ICU).

Adaptive Probe Off Detection (APOD) sensitivity is the recommended sensitivity mode where there is a high probability of the sensor becoming detached. It is also the suggested mode for care areas where patients are not visually monitored continuously. This mode delivers enhanced protection against erroneous pulse rate and arterial oxygen saturation readings when a sensor becomes inadvertently detached from a patient due to excessive movement.

Maximum sensitivity is recommended for use on patients with weak signals (e.g. high ambient noise and/or patients with very low perfusion) and for use during procedures or when clinician and patient contact is continuous such as in higher acuity settings.

To set SpO

2

sensitivity, follow this procedure:

1.

Select the SpO

2

numeric area or waveform area to enter the SpO2 dialog.

2.

Select the Setup tab.

3.

Set Sensitivity to Maximum, Normal, or APOD .

CAUTION

When using the Maximum Sensitivity setting, performance of "Sensor Off" detection may be compromised. If the equipment and the sensor becomes detached from the patient, the potential for false readings may occur due to environmental noise such as light, and vibration.

Configuring the monitor to “Load Latest Configuration” as the default configuration may result in

Masimo SpO

2

being set to Maximum sensitivity mode on power up or after admitting a new patient.

Maximum sensitivity is recommended for use during procedures or when clinician and patient contact is continuous, such as in higher acuity settings. Maximum sensitivity is not recommended for care areas where patients are not monitored visually as “Sensor Off” detection may be compromised. Refer to

Section 20.4 Setting Default Configuration

for managing configuration.

10.6.4

Enabling FastSAT (for Masimo SpO

2

)

FastSAT enables rapid tracking of arterial oxygen saturation changes as may be required in urgent situations.

When FastSAT is switched on, the averaging algorithm evaluates all the SpO

2

values and provides an averaged

SpO

2

value that is a better representation of the patient’s current oxygen saturation status.

The reliability of FastSAT is dependent on the setting for the averaging time and the input signal. FastSAT is disabled by default. To enable FastSAT, follow this procedure:

1.

Select the SpO

2

numeric area or waveform area to enter the SpO2 menu.

2.

Select the Setup tab.

3.

Switch on FastSAT .

10 - 6 BeneVision N1 Patient Monitor Operator’s Manual

10.6.5

Displaying SIQ (for Masimo SpO

2

)

The signal quality indicator (SIQ) displays below the Pleth waveform. The SIQ is conveyed by vertical bars. The height of the bar provides an assessment of the confidence in the displayed SpO

2

value. The SpO be used to identify the occurrence of a patient ‘s pulse.

2

SIQ can also

The following picture shows the SpO

2

SIQ:

(1)

(1) Signal quality indicator (SIQ)

To show SpO

2

SIQ, follow this procedure:

1.

Select the SpO

2

numeric area or waveform area to enter the SpO2 menu.

2.

Select the Setup tab.

3.

Switch on Display SIQ .

10.6.6

Changing Averaging Time (for Masimo SpO

2

)

The SpO

2

value displayed on the monitor screen is the average of data collected within a specific time. The shorter the averaging time is, the quicker the monitor responds to changes in the patient’s oxygen saturation level. Contrarily, the longer the averaging time is, the slower the monitor responds to changes in the patient’s oxygen saturation level, but the SpO

2

measurement is more stable. For critically ill patients, selecting a shorter averaging time will help with understanding the patient’s state.

To set the averaging time, follow this procedure:

1.

Select the SpO

2

numeric area or waveform area to enter the SpO2 dialog.

2.

Select the Setup tab.

3.

Set Averaging .

10.6.7

Monitoring SpO

2

and NIBP Simultaneously

When monitoring SpO

2

SpO

2

and NIBP on the same limb simultaneously, you can switch on NIBP Simul to lock the

alarm status until the NIBP measurement ends. If you switch off NIBP Simul , low perfusion caused by NIBP measurement may lead to inaccurate SpO

2

readings and therefore cause false physiological alarms.

To set the NIBP Simul , follow this procedure:

1.

Select the SpO

2

numeric area or waveform area to enter the SpO2 dialog.

2.

Select the Alarm tab.

3.

Set NIBP Simul .

10.6.8

Changing the Sweep Speed of the Pleth Waveform

To set the sweep speed of Pleth waveform, follow this procedure:

1.

Select the SpO

2

numeric area or waveform area to enter the SpO2 dialog.

2.

Select the Setup tab.

3.

Set Speed .

10.7

Changing the PR Settings

10.7.1

Changing the PR Alarm Settings

To change the PR alarm settings, follow this procedure:

1.

Select the SpO

2

numeric area or waveform area to enter the SpO2 dialog.

2.

Select the PR tab.

BeneVision N1 Patient Monitor Operator’s Manual 10 - 7

3.

Enter the password if required. For more information refer to 21.13.3 Selecting Password for User

Authentication

.

4.

Set the alarm properties as desired.

10.7.2

Changing the QRS Volume

If the Alarm Source is set to PR , the QRS tone is derived from PR measurements. To set the QRS volume, follow this procedure:

1.

Select the SpO

2

numeric area or waveform area to enter the SpO2 dialog.

2.

Select the PR tab.

3.

Select the Setup tab.

4.

Set QRS Volume .

If the SpO

2

value is valid, the monitor also adjusts the QRS tone (pitch tone) according to the SpO

2

value. For

information, see 21.15.3 Setting the SpO

2 Tone Mode

.

NOTE

Changing the QRS volume settings in the PR Setup page also changes the QRS volume settings in the

Setup page of the ECG dialog.

10.7.3

Setting the PR Source

Current pulse source is displayed in the PR numeric area if current PR source is not SpO

2

. The PR from current pulse source has the following characteristics:

PR is stored in the monitor’s database and can be reviewed in the graphic and tabular trends.In graphic trends, as the PR curve has the same color as that of current PR source.

PR is sent via the network to the CMS, if available.

To set which parameter is used as a PR source, follow this procedure:

1.

Select the SpO

2

numeric area or waveform area to enter the SpO2 dialog.

2.

Select the PR tab.

3.

Select the Setup tab.

4.

Set PR Source .

The dropdown list of the PR Source displays the currently available PR sources from top to bottom by priority.

When you select Auto , the system will automatically select the first option as the PR source. If the current PR source is unavailable, the system will automatically switch PR Source to Auto . When you select IBP , the system will automatically select the first pressure label as the PR source.

10.7.4

Showing/Hiding PR

You can set whether to display the PR value in the SpO

2

parameter area. To do so, follow this procedure:

1.

Select the SpO

2

numeric area or waveform area to enter the SpO2 menu.

2.

Select the PR tab.

3.

Select the Setup tab.

4.

Switch on or off Display PR.

10.8

Displaying SpO

2

Statistics

You can show SpO

2 statistics for a defined period of time. To do so, follow this procedure:

1.

Access the Tile Layout in either of the following ways:

Select the Screen Setup quick key

→ select the Tile Layout tab.

◆ Select the Main Menu quick key

→ from the Display column select Tile Layout .

10 - 8 BeneVision N1 Patient Monitor Operator’s Manual

2.

Select the parameter numeric area where you want to display SpO

2

statistics, and then from the popup list select SpO2

SpO2 Statistics .

The following figure shows the SpO

2

statistics area.

(1)

(2)

(3)

(1) Duration of SpO

2 statistics

(2) Results of SpO

2 statistics

(3) Sections for statistics: The section in green indicates the target range.

10.8.1

Selecting the Range of each SpO

2

Section and the Target Section

To define the SpO

2 range of each section, follow this procedure:

1.

Select the SpO

2

statistics area.

2.

In the To column set the SpO2 value at which each section ends. Changing the value in the To column automatically changes the value in the From column of the next section.

3.

In the Target column select the section to be used as the target section. The target section is highlighted in green in the SpO

2

statistics area.

10.8.2

Selecting the SpO

2

Statistics Length

The time period over which the SpO

2

statistics are calculated is configurable. From the SpO

2

statistics area, select a new duration from the popup menu.

10.9

SpO

2

Troubleshooting

This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting service. If the problem persists, contact your service personnel.

NOTE

For the physiological and technical alarm messages, see Appendix D Alarm Messages .

Problem

Do not see SpO

2

numeric area or waveform area on the main screen

Solution

1. Check that the SpO

2 is set to display in the Screen Setup

→ →

Tile Layout

page. For more information, see 3.9.2 Displaying

Parameter Numerics and Waveforms

.

2. Check that the SpO

SpO

2

2 parameter switch is enabled. If not, enable the

measurement .

For more information, see

3.9.1 Switching On or

Off a Parameter

.

3. Check that the cable connections of the SpO

2

sensor and the extension cable are tight. Replace the SpO

2

sensor or the extension cable if needed.

BeneVision N1 Patient Monitor Operator’s Manual 10 - 9

Problem

Dashes “- -” display in place of numerics

Low amplitude SpO

2

signal

SpO

2

value is inaccurate

Solution

1. Check that the cable connections of SpO

2 sensor and the extension cable are tight. Replace the SpO

2

sensor or the extension cable if needed.

2. Reconnect the SpO

2

sensor if the alarm SpO2 Sensor Off appears.

3. Check the PI value. If the PI value is too low, adjust the SpO

2

sensor, or apply the sensor to a site with better perfusion.

4. Move the sensor to a place with weaker ambient light, or cover the sensor to minimize the ambient light if the alarm SpO2 Too Much

Light appears.

1. The SpO

2

sensor and NIBP cuff are placed on the same limb.

Change the monitoring site if necessary.

2. Check the PI value. If the PI value is too low. Adjust the SpO

2

sensor, or apply the sensor to a site with better perfusion.

1. Check the patient’s vital signs.

2. Check for conditions that may cause inaccurate SpO

2

readings. For more information, see

10.3 SpO

2

Measurement Limitations

.

3. Check the monitor, the SpO

2

module or the MPM for proper functioning.

10.10

Nellcor Information

Nellcor Patents

This posting serves as notice under 35 U.S.C.§287(a) for Covidien patents: http://www.covidien.com/patents.

No Implied License

Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.

10.11

Masimo Information

Masimo Patents

This posting serves as notice under 35 U.S.C.§287(a) for Masimo patents: http://www.masimo.com/patents.htm.

No Implied License

Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.

10.12

Masimo End-User License Agreement

THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU (“PURCHASER”) AND SHENZHEN MINDRAY. IF YOU DO

NOT AGREE TO THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE ENTIRE PACKAGE, INCLUDING ALL

ACCESSORIES, IN THEIR ORIGINAL PACKAGE, WITH YOUR SALES RECEIPT TO SHENZHEN MINDRAY FOR A FULL

REFUND.

1.

Grant of License. In consideration of payment of the license fee, which is part of the price paid for this product, Shenzhen Mindray grants to Purchaser a nonexclusive, nontransferable license, without right to sublicense, to use the copy of the incorporated software/firmware, and documentation in connection with

Purchaser's use of the Masimo Products for their labeled purpose. Shenzhen Mindray reserves all rights not expressly granted to Purchaser.

10 - 10 BeneVision N1 Patient Monitor Operator’s Manual

2.

Ownership of Software/Firmware. Title to, ownership of, and all rights and interests in, any Masimo software and/or firmware and the documentation, and all copies thereof, remain at all times vested in

Masimo Corporation, licensor to Shenzhen Mindray, and they do not pass to Purchaser.

3.

Assignment. Purchaser shall not assign or transfer this License, in whole or in part, by operation of law or otherwise, without Shenzhen Mindray's prior written consent; any attempt without such consent, to assign any rights, duties or obligations arising hereunder shall be void.

4.

Copy Restrictions. The software/firmware, mask works, circuit board layouts, and accompanying written materials are copyrighted. Unauthorized copying of the software, including software that has been modified, merged, or included with other software, or other written materials is expressly forbidden. You may be held legally responsible for any copyright infringement that is cause or incurred by your failure to abide by the terms of this license. Nothing in this license provides any rights beyond those provided by 17

U.S.C. §117.

5.

Use Restriction. As the Purchaser, you may physically transfer the products from one location to another provided that the software/firmware is not copied. You may not electronically transfer the software/ firmware from the products to any other device. You may not disclose, publish, translate, release distribute copies of, modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works based on the Masimo Product, the software/firmware, or the written materials without the prior written consent of Masimo. Masimo Sensors that are designated for single use are licensed under Masimo patents for use on a single patient only, and are not sold. There is no license, implied or otherwise, that would allow use of single use Masimo Sensors beyond their intended single use. After use of single use Masimo Sensors, there is no further license granted by Masimo to use the sensors and they must be discarded.

6.

Transfer Restrictions. The software/firmware is licensed to the Purchaser, and may not be transferred to anyone, except other end-users, without the prior written consent of Shenzhen Mindray. In no event may you transfer, assign, rent, lease, sell, or otherwise dispose of the software/firmware or the products on a temporary basis.

7.

Beneficiary. Masimo Corporation is a Beneficiary of this Agreement and has the right to enforce its provisions.

U.S. Government Rights: If you are acquiring software (including the related documentation) on behalf of any part of the United States Government, the following provisions apply: the software is deemed to be “commercial software” and “commercial computer software documentation,” respectively pursuant to DFAR Section 227.7202

FAR 12.212, as applicable. Any use, modification, reproduction, release, performance, display or disclosure of the software (including the related documentation) by the U.S. Government or any of its agencies shall be governed solely by the terms of this Agreement and shall be prohibited except to the extent expressly permitted by the terms of this agreement.

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10 - 12 BeneVision N1 Patient Monitor Operator’s Manual

11

Monitoring Temperature (Temp)

11.1

Temperature Introduction

The monitor can continuously monitor the patient’s skin temperature and core temperature. Thermally sensitive resistors (thermistors) are used, and are based on the principle that electrical resistance of the thermistor changes as temperature changes. The resistance change of the thermistors is used to calculate the temperature.

Up to two temperature sites can be monitored simultaneously and the difference between two measured sites is calculated.

Temperature monitoring is intended for adult, pediatric and neonatal patients.

11.2

.

Temperature Safety Information

CAUTION

Verify that the probe detection program works correctly before monitoring. Remove the temperature probe cable from the temperature probe connector, and check that the monitor can display the alarm messages and give alarm tones correctly.

11.3

Temperature Display

The following figure shows the Temp numeric area for temperature monitoring with the monitor. Your display may be configured to look different.

(3)

(1)

(2)

(1)

(2) (4)

(3)

(1) Temperature site ( 2 ) Temperature alarm limits (3) Temperature value

(4) Temperature difference (

T): Difference between two temperature sites. It displays only when

T is switched on.

11.4

Preparing for Temperature Monitoring

To prepare temperature monitoring, follow this procedure:

1.

Select an appropriate probe for your patient according to patient category and measured site.

2.

Plug the probe or temperature cable to the temperature connector. If using a disposable probe, connect the probe to the temperature cable.

3.

Follow the probe manufacturer’s instructions to connect the probe to the patient.

BeneVision N1 Patient Monitor Operator’s Manual 11 - 1

11.5

Changing Temperature Settings

11.5.1

Setting the Temperature Alarm Properties

To set the temperature alarm properties, follow this procedure:

1.

Select the temperature numeric area to enter the Temp dialog.

2.

Select the Alarm tab.

3.

Enter the password if required. For more information, refer to 21.13.3 Selecting Password for User

Authentication

.

4.

Set the alarm properties as desired.

11.5.2

Selecting the Temperature Label

Select the temperature label according to the measurement site. To do so, follow this procedure:

1.

Select the temperature numeric area to enter the Temp dialog.

2.

Select the Setup tab.

3.

Set the temperature label.

Label

T1

T2

T skin

T core

T axil

T naso

T eso

T rect

Description

Temperature of application site 1

Temperature of application site 2

Skin temperature

Core temperature

Axillary temperature

Nasopharyngeal temperature

Esophageal temperature

Rectal temperature

Label

T amb

T airw

T vesic

T blood

T myo

T tymp

T cereb

Description

Ambient temperature

Airway temperature

Vesical temperature

Blood temperature

Myocardial temperature

Tympanic temperature

Cerebral temperature

11.5.3

Displaying the Temperature Difference

To display the temperature difference between two measurement sites monitored by the same temperature module, switch on

T. To do so, follow this procedure:

1.

Select the temperature numeric area to enter the Temp dialog.

2.

Select the Setup tab.

3.

Switch on ∆ T .

11.6

Temperature Troubleshooting

This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting service. If the problem persists, contact your service personnel.

NOTE

For the physiological and technical alarm messages, see Appendix D Alarm Messages

.

11 - 2 BeneVision N1 Patient Monitor Operator’s Manual

Problem

Do not see Temp numeric area on the main screen

Measurement fails/’--’ is displayed in the Temp numeric area

Solution

1. Check that if the Temp parameter switch is enabled. If not, enable

the Temp measurement. For more information, see 3.9.1 Switching

On or Off a Parameter

.

2. Check that the connections of the temperature probe and the temperature cable are tight.

1. If using a disposable probe, check the connection between the probe and the temperature cable.

2. Try using a known good probe in case the sensor is damaged.

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11 - 4 BeneVision N1 Patient Monitor Operator’s Manual

12

Monitoring Noninvasive Blood Pressure (NIBP)

12.1

NIBP Introduction

The monitor uses the oscillometric method for measuring Non-Invasive Blood Pressure (NIBP). NIBP measurement is based on the principle that pulsatile blood flow through an artery creates oscillations of the arterial wall. The oscillometric device uses a blood pressure cuff to sense these oscillations that appear as tiny pulsations in cuff pressure. The oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish. The oscillometric method measures the mean pressure and determines the systolic and diastolic pressures.

NIBP monitoring is intended for adult, pediatric, and neonatal patients.

NOTE

Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method or an intra-arterial blood pressure measurement device, within the limits prescribed by the American National Standard: manual, electronic, or automated sphygmomanometers.

NIBP measurement can be performed during electro-surgery and discharge of a defibrillator.

12.2

NIBP Safety Information

WARNING

Be sure to select the correct patient category setting for your patient before NIBP measurement. Do not apply the higher adult settings for pediatric or neonatal patients. Otherwise, it may present a safety hazard.

Do not measure NIBP on patients with sickle-cell disease or on the limb where skin damage has occurred or is expected.

Use clinical judgment to determine whether to perform frequent unattended blood pressure measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff.

Do not use the NIBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation.

Do not apply cuff on the arm on the side of a mastectomy or lymph node clearance.

Continuous cuff pressure due to connection tubing kinking may cause blood flow interference and result in harmful injury to the patient.

NIBP reading can be affected by the measurement site, the position of the patient, exercise, or the patient's physiologic condition. If you doubt the NIBP measurements, determine the patient’s vital signs by alternative means, and then verify that the monitor is working correctly.

Devices that exert pressure on tissue have been associated with purpura, ischemia, and neuropathy.

Inspect the application site regularly to ensure skin quality and inspect the extremity of the cuffed limb for normal color, warmth and sensitivity. If the skin quality changes, or if the extremity circulation is being affected, move the cuff to another site or stop the blood pressure measurements immediately. Check more frequently when making automatic or STAT measurements. Auto NIBP measurements with one and two minute intervals are not recommended for extended periods of time.

Do not modify or replace connectors of the NIBP air hose except with mindray-approved connectors.

Use neonatal and infant cuffs with CM1901 hoses only. Use pediatric/adult cuffs with CM1903 hoses only.

BeneVision N1 Patient Monitor Operator’s Manual 12 - 1

Never connect intra-arterial or intra-venous lines, or any other incompatible connectors to the NIBP hose. This can cause serious injury or death.

NIBP diagnostic significance must be decided by the hospital’s clinician staff.

CAUTION

Measuring NIBP on patients connected to an Intra Aortic Balloon Pump (IABP) machine may result in the NIBP measurement, including PR, to be inaccurate or fail.

Only use parts and accessories specified in this manual. Follow the instructions for use and adhere to all warnings and cautions.

Using IABP may cause NIBP, including PR, measurements inaccurate or failed.

Accuracy of NIBP measurement depends on using a cuff of proper size. It is essential to measure limb circumference and choose a cuff with proper size.

12.3

NIBP Measurement Limitations

Measurements are impossible with heart rate extremes of less than 30 bpm or greater than 300 bpm, or if the patient is on a heart-lung machine. The measurement may be inaccurate or impossible in the following situations:

Regular arterial pressure pulses are hard to detect

Excessive and continuous patient movement such as shivering or convulsions

Cardiac arrhythmias

Rapid blood pressure changes

Severe shock or hypothermia that reduces blood flow to the peripheries

On an edematous extremity

Obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery

NOTE

The effectiveness of this sphygmomanometer has not been established in pregnant women, including pre-eclamptic patients.

12.4

Measurement Modes

The monitor provides the following NIBP measurement modes:

Manual: measurement on demand.

Auto: repeated measurements at set interval.

STAT: continual rapid series of measurements over a five-minute period.

Sequence: continually automatic measurement at set durations and intervals.

12 - 2 BeneVision N1 Patient Monitor Operator’s Manual

12.5

NIBP Display

The NIBP display shows only numerics.

(3) (4) (5)

(2)

(1)

(6)

(7)

(8)

(11) (10) (9)

(1) Systolic pressure alarm limits

(2) NIBP unit: mmHg or kPa

(3) The last NIBP measurement time

(4) Time to the next measurement (for Auto mode and Sequence mode)

(5) Measurement mode: for Auto NIBP, interval is displayed; for Sequence mode, the current phase and interval are displayed

(6) Diastolic pressure

(7) Diastolic pressure alarm limits

(8) Mean pressure alarm limits

(9) Mean pressure (displayed after measurement completed) or cuff pressure (displayed during the measurement)

(10) Systolic pressure (11) Pulse Rate

NOTE

If NIBP measurement fails, “XX” is displayed; if NIBP measurement is not taken or NIBP measurement exceeds its measurement ranges, “--” is displayed.

NIBP numerics in black color with a light outline indicate that the measurement is old and exceeds the configured NIBP Measurement Timeout time (see section

21.5.7 Setting Parameter Measurement

Timeout ). These NIBP values are not recommended for reference.

12.6

Preparing for NIBP Measurements

12.6.1

Preparing the Patient for NIBP Measurements

In normal use, perform NIBP measurement on a patient who is in the following position:

Comfortably seated

Legs uncrossed

Feet flat on the floor

Back, arm and feet supported

NOTE

It is recommended that the patient remains calm and relaxes as much as possible before performing the measurement and that the patient does not talk during the measurement.

Other factors that have been shown to result in an overestimation of blood pressure are labored breathing, full bladder, pain etc.

BeneVision N1 Patient Monitor Operator’s Manual 12 - 3

12.6.2

Placing the NIBP Cuff

To place the NIBP cuff, follow this procedure:

1.

Verify that the patient category setting is correct.

2.

Connect the air tubing to the NIBP connector.

3.

Select an appropriately sized cuff for the patient, and then wrap it around the limb directly over the patient’s skin as follows: a Determine the patient

’ s limb circumference.

b Select an appropriate cuff by referring to the limb circumference marked on the cuff. The width of the cuff should be 40% (50% for neonates) of the limb circumference, or 2/3 of the length of the upper arm or the thigh. The inflatable part of the cuff should be long enough to encircle to overlap at least

50% to 80% of the limb. c Apply the cuff to the patient ’ s upper arm or leg and make sure the Φ marking on the cuff matches the artery location. The cuff should fit snugly, but with enough room for two fingers to be placed between the cuff and the patient ’ s arm (on adults), and loosely on neonates with little or no air present within the cuff. Otherwise it may cause discoloration and ischemia of the extremities. Make sure that the cuff index line falls within the range markings on the cuff. If it does not, use a cuff that fits better.

d Middle of the cuff should be at the level of the right atrium of the heart. If it is not, use the measurement correction formula to correct the measurement. For more information, see

12.8.7 Setting the NIBP Display Format

.

4.

Connect the cuff to the air tubing. Avoid compression or restriction of pressure tubes. Air must pass unrestricted through the tubing.

CAUTION

Do not touch or apply external pressure against the cuff and air tubing during NIBP measurement.

This may cause inaccurate blood pressure values.

Use care when placing the cuff on an extremity used for monitoring other patient parameters.

12.7

Starting and Stopping NIBP Measurements

Start and stop NIBP measurement by selecting the NIBP quick keys or from the NIBP dialog.

Task

Start a manual measurement

By Quick Key

NIBP Start/Stop quick key

Start auto NIBP series

Start NIBP sequence measurement

Start STAT measurement

NIBP Start/Stop quick key

NIBP Measure quick key

Interval

NIBP Measure

Sequence

NIBP Measure

quick key

quick key

Stop the current NIBP measurements

End auto NIBP series or NIBP

Sequence

Stop STAT measurement and end series

NIBP Start/Stop quick key

/

NIBP Start/Stop quick key

→ select

STAT

From NIBP dialog

Start NIBP button

Setup tab

set Interval

Start NIBP button

Sequence tab → set NIBP sequence

→ Start NIBP button

STAT button

Stop NIBP button

NIBP Stop All button

Stop NIBP or NIBP Stop All button

12 - 4 BeneVision N1 Patient Monitor Operator’s Manual

12.8

Changing NIBP Settings

12.8.1

Setting the NIBP Alarm Properties

To set the NIBP alarm properties, follow this procedure:

1.

Select the NIBP numeric area to enter the NIBP dialog.

2.

Select the Alarm tab.

3.

Enter the password if required. For more information, refer to 21.13.3 Selecting Password for User

Authentication

.

4.

Set the alarm properties as desired.

12.8.2

Setting the Initial Cuff Inflation Pressure

To set initial cuff inflation pressure, follow this procedure:

1.

Select the NIBP numeric area to enter the NIBP dialog.

2.

Select Initial Pressure , and then select the appropriate setting.

NOTE

For known hypertensive patients, you need to set initial cuff pressure to a higher value to reduce the measurement time.

12.8.3

Setting the NIBP Interval

For auto NIBP measurement, you need to set the interval between two NIBP measurements. To set the NIBP interval, follow this procedure:

1.

Select the NIBP numeric area to enter the NIBP dialog.

2.

Set Interval . Selecting Manual switches to manual mode.

NOTE

NIBP Measure dialog gives quick access to starting and setting the interval. Selecting an option from the NIBP Measure dialog will change the NIBP interval to that selection and start the NIBP measurement.

12.8.4

Selecting NIBP Start Mode

Start mode defines how future NIBP measurements are initiated with automatic measurement mode. To set the start mode, follow this procedure:

1.

Select the NIBP numeric area to enter the NIBP dialog.

2.

Select Start Mode .

Clock : after the first measurement, the monitor automatically synchronizes NIBP automatic measurements with the real time clock. For example, if Interval is set to 20 min , and NIBP auto measurement is started at 14:03, the next measurement will be taken at 14:20, and then at 14:40,

15:00, and so on.

◆ Interval : after the first measurement, the monitor automatically repeats measurements at set interval.

For example, if Interval is set to 20 min , and NIBP auto measurement is started at 14:03, the next measurement will be taken at 14:23, and then at 14:43, 15:03, and so on.

12.8.5

Enabling the NIBP End Tone

The monitor can issue a reminder tone at the completion of NIBP measurement. The NIBP End Tone is off by default. To switch on the NIBP end tone, follow this procedure:

1.

Select the NIBP numeric area to enter the NIBP dialog.

BeneVision N1 Patient Monitor Operator’s Manual 12 - 5

2.

Switch on NIBP End Tone .

12.8.6

Setting NIBP Sequence

NIBP sequence measurement can have up to five phases: A, B, C, D, and E. The duration and interval of each phase can be set individually.

To set NIBP sequence, follow this procedure:

1.

Select the NIBP numeric area to enter the NIBP dialog.

2.

Select the Sequence tab.

3.

Set Duration and Interval of each phase.

12.8.7

Setting the NIBP Display Format

To set the NIBP display format, follow this procedure:

1.

Select the NIBP numeric area to enter the NIBP menu.

2.

Select the Setup tab.

3.

Set Display Format .

12.8.8

Setting the NIBP Alarm Limits Display Switch

To set whether to display the alarm limits of diastolic NIBP and mean NIBP, follow this procedure:

1.

Select the NIBP numeric area to enter the NIBP menu.

2.

Select the Setup tab.

3.

Switch on or off Display Alarm Limits.

12.8.9

Showing/Hiding PR

You can set whether to display the PR value in the NIBP parameter area. To do so, follow this procedure:

1.

Select the NIBP numeric area to enter the NIBP menu..

2.

Select the Setup tab.

3.

Switch on or off Display PR.

12.8.10

Correcting the NIBP Measurements

The middle of the cuff should be at the level of right atrium. If the limb is not at the heart level, the measurement should be corrected as follows:

Add 0.75 mmHg (0.10 kPa) to the displayed value for each centimetre higher.

Deduct 0.75 mmHg (0.10 kPa) to the displayed value for each centimeter lower.

12.9

Assisting Venous Puncture

You can use the NIBP cuff to cause sub-diastolic pressure to block the venous blood vessel and therefore help venous puncture. To assist venous puncture, follow this procedure:

1.

Select the NIBP numeric area → Setup tab.

2.

p Set Venipuncture Pressure .

3.

Select Venipuncture at the bottom of the dialog.

4.

Puncture vein and draw blood sample.

5.

Select the NIBP Start/Stop quick key to deflate the cuff. If the cuff is not manually deflated, the cuff automatically deflates after a fixed period of time (170 seconds for adult and pediatric patient, 85 seconds for neonatal patient).

During venous puncture, pay attention to the cuff pressure and the remaining time displayed in the NIBP numerics area.

12 - 6 BeneVision N1 Patient Monitor Operator’s Manual

12.10

NIBP Troubleshooting

This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting for services. If the problem persists, contact your service personnel.

NOTE

For the physiological and technical alarm messages, see Appendix

D Alarm Messages

.

Problem

Cannot see NIBP numeric area on the main screen

Solution

1. Check that the NIBP is set to display in the Screen Setup

Tile Layout

page. For more information, see.

3.9.2 Displaying Parameter Numerics and

Waveforms

2. Check that if the NIBP parameter switch is enabled. If not, enable the NIBP measurement. For more information, see

3.9.1 Switching On or Off a

Parameter

.

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13

Monitoring Invasive Blood Pressure (IBP)

13.1

IBP Introduction

This patient monitor can monitor up to four invasive blood pressures and displays the systolic, diastolic and mean pressures and a waveform for each pressure.

IBP monitoring is intended for adult, pediatric, and neonatal patients. PAWP monitoring is only intended for adult and pediatric patients.

(2) (3)

(1)

(1)

(1)

(1) IBP cable connector (2) IBP dialog hard key (3) Zero IBP hard key

NOTE

In order for the N1 to connect to the external IBP module and perform IBP monitoring, the N1system software V01.11 and above is required.

13.2

IBP Safety Information

WARNING

Use only pressure transducers specified in this manual. Never reuse disposable pressure transducers. See chapter

25 Accessories for specified pressure transducers.

Make sure that the applied parts never contact other conductive parts.

To reduce the hazard of burns during high-frequency surgical procedures, ensure that the monitor’s cables and transducers never come into contact with the high-frequency surgical units.

When using accessories, their operating temperature should be taken into consideration. For more information, see instructions for use of accessories.

All invasive procedures involve risks to the patient. Use aseptic technique. Follow catheter manufacturer's instructions.

Mechanical shock to the invasive blood pressure transducer may cause severe shifts in zero balance and calibration, and cause erroneous readings.

The neutral electrode of the electro-surgery unit (ESU) shall properly contact the patient. Otherwise, burns may result.

BeneVision N1 Patient Monitor Operator’s Manual 13 - 1

CAUTION

Measuring IBP on patients connected to an Intra Aortic Balloon Pump (IABP) machine may result in the IBP measurement, including PR, to be inaccurate or fail.

NOTE

PAWP monitoring is available only when using an external display.

13.3

Preparing for IBP Monitoring

13.3.1

IBP Equipment to Patient Connection

(1)

(2)

(4)

(5)

(3)

(5)

(1) Pressure bag

(3) IBP cable

(5) Three-way valve

(2) IBP connector

(4) IBP transducer

13.3.2

Measuring an Invasive Blood Pressure

To monitor IBP, follow this procedure:

1.

Connect one end of the IBP cable to the IBP cable connector, and the other end to the IBP transducer.

2.

Flush the IBP transducer system to exhaust all air from the tubing according to the manufacturer’s instructions. Ensure that the system is free of air bubbles.

3.

Connect the IBP transducer to the patient, making sure that the transducer is at the same horizontal level as the heart.

4.

Select the proper pressure label for currently measured pressure. For more information, see

13.6.2 Changing the Pressure Label .

5.

Zero the IBP transducer. For more information, see.

13.3.3 Zeroing the IBP transducer . After a successful

zeroing, turn off the three-way valve to the air and turn on the three-way valve to the patient.

13 - 2 BeneVision N1 Patient Monitor Operator’s Manual

CAUTION

Make sure that all the transducers are zeroed correctly before making IBP measurements.

Make sure that all air bubbles have been flushed from the IBP transducer system before making IBP measurements.

If measuring intracranial pressure (ICP) with a sitting patient, level the transducer with the top of the patient’s ear. Incorrect leveling may give incorrect values (not applicable if measuring ICP with the

Codman ICP transducer).

NOTE

If two invasive blood pressures measurements are needed, use the IBP extension cable with dualreceptacle (PN: 040-001029-00) instead of the IBP cable.

13.3.3

Zeroing the IBP transducer

To avoid inaccurate pressure readings, the monitor requires a valid zero. Zero the transducer in accordance with your hospital policy. The IBP transducer should be zeroed in the following conditions:

The IBP transducer or adapter cable is reconnected.

The monitor restarts.

The readings are in doubt.

The monitor displays the prompt message Zero Required .

To zero the transducer, follow this procedure:

1.

Connect the IBP transducer, the IBP adapter cable and the monitor.

2.

Turn off the three-way valve (the one near the transducer) to the patient, in order to vent the transducer to the atmospheric pressure.

3.

Select the numeric area (such as the Art numeric area), and then select Zero button.

4.

After the zero calibration is completed, close the three-way valve to the air and open the three-way valve to the patient.

13.4

Zero calibration may fail in case of pressure fluctuation or pressure exceeding the calibration range. If zero calibration fails, follow this procedure:

1.

Check that the three-way valve (the one near the transducer) is open to the air.

2.

Perform zero calibration again. Do not sway the IBP transducer and tubing during zero calibration.

Measuring ICP Using the Codman ICP Transducer

13.4.1

Zeroing the Codman ICP transducer

The Codman ICP transducer (Model: 82-6653) must be zeroed before use. To zero the ICP transducer, follow this procedure:

1.

Connect the ICP transducer, the ICP adapter cable and the monitor.

2.

Follow the manufacturer’s instructions to prepare the ICP transducer.

3.

Zero the ICP transducer: when the message Zero Reference is displayed in the ICP numeric area, select the

ICP waveform area or numeric area to enter the ICP dialog

select the Zero tab

→ select the Zero button.

4.

Record the zero reference value on the blank area of the ICP transducer for reference.

If the ICP transducer zero calibration failed or the zero reference value is in doubt, perform the zero calibration again.

13.4.2

Measuring ICP

To perform the ICP measurement, follow this procedure:

BeneVision N1 Patient Monitor Operator’s Manual 13 - 3

1.

Zero the Codman ICP transducer. For more information, see section 13.4.1 Zeroing the Codman ICP transducer

.

2.

Disconnect the ICP transducer and ICP adapter cable. Follow the manufacturer’s instructions to apply the

ICP transducer to the patient.

3.

Reconnect the ICP transducer and ICP adapter cable.

4.

Check that the zero reference value displayed on the monitor is consistent with that recorded on the ICP transducer.

◆ Consistent: select Accept .

◆ Inconsistent: input the zero reference value recorded on the ICP transducer, and select Accept .

If the patient being monitored for ICP must be transported, and N1 is not used for transport, check that the transport monitor supports the Codman ICP transducer. If the transport monitor does not support the Codman

ICP transducer, do not use it for ICP monitoring.

If the transport monitor supports the Codman ICP transducer, follow this procedure to transport the patient:

1.

Disconnect the ICP adapter cable from the N1.

2.

Connect the ICP adapter cable and the transport monitor.

3.

Check that the zero reference value displayed on the monitor is consistent with that recorded on the ICP transducer.

◆ Consistent: select Accept .

◆ Inconsistent: input the zero reference value recorded on the ICP transducer, and select Accept .

CAUTION

If monitors of different brands are used to zero the Codman ICP transducer, the zero reference values can be different. Use a Mindray monitor to Zero the Codman ICP transducer if you will take

ICP measurement using a Mindray monitor. Otherwise the ICP measurement could be inaccurate.

13.5

IBP Display

The IBP measurement is displayed on the monitor as a waveform and numeric pressures. For arterial pressure, the IBP numeric area displays systolic pressure, diastolic pressure and mean pressure. For venous pressure, the

IBP numeric area displays only the mean pressure. The figure below shows the waveform and numerics for the

Art pressure.

(1) (2) (3) (4) (5)

(7) (6)

(1) Pressure label

(3) Pressure Unit

(5) Diastolic pressure

(7) PPV measurement

(2) Waveform

(4) Systolic pressure

(6) Mean pressure

For some pressures, the parameter window may show the mean pressure only. For different pressures, their defaults unit may be different. If the Art and ICP pressures are measured simultaneously, the ICP parameter area will display numeric CPP, which is obtained by subtracting ICP from the Art mean.

13.5.1

Overlapping IBP Waveforms

The IBP waveforms can be displayed together. To combine IBP waveforms, follow this procedure:

13 - 4 BeneVision N1 Patient Monitor Operator’s Manual

1.

Access Tile Layout by either of the following ways:

◆ Select the Screen Setup quick key → select the Tile Layout tab.

◆ Select Main Menu quick key → from the Display column select Tile Layout .

2.

Select the waveform area where you want to display the overlapped IBP waveforms, and then select the IBP waves to be overlapped on the left side of the same line.

3.

Repeat step 2 in another waveform area if needed.

4.

Select to save the setting and exit the screen. The main screen will display the overlapped IBP waves.

Selecting the overlapped IBP waveforms on the main screen opens the Overlapping Waveform Setup dialog, where you can make the following settings:

■ Scale

◆ Set Left Scale for the arterial pressure.

◆ Set Right Scale for the venous pressure.

◆ Set CVP Scale individually if the CVP waveform is combined and CVP unit is different from IBP unit.

◆ Set ICP Scale individually if the ICP waveform is combined and ICP unit is different from IBP unit.

◆ Set PA Scale individually if the PA waveform is combined.

Switch on or off Gridlines to show or hide gridlines in the overlapped waveform area.

Set Speed for the overlapped waveforms.

NOTE

The unit of CVP scale is consistent with the CVP parameter unit.

13.6

Changing IBP Settings

13.6.1

Changing the IBP Alarm Settings

To change the IBP alarm settings, follow this procedure:

1.

Select the IBP numeric area or waveform area to enter the corresponding pressure dialog.

2.

Select the Alarm tab.

3.

Enter the password if required. For more information, refer to 21.13.3 Selecting Password for User

Authentication

.

4.

Set the alarm properties of pressure.

13.6.2

Changing the Pressure Label

The pressure label is a unique identifier for each type of pressure. Therefore, it is recommended to select the proper pressure label for the source of the pressure being monitored.

To select the pressure label, follow this procedure:

1.

Select the IBP numeric area or waveform area to enter the corresponding pressure dialog.

2.

Select the Setup tab.

BeneVision N1 Patient Monitor Operator’s Manual 13 - 5

3.

Set IBP1 Label or IBP2 Label .

Label

Art

Ao

BAP

CVP

RAP

UVP

P1 to P4

Description

Arterial blood pressure

Aortic pressure

Brachial arterial pressure

Central venous pressure

Right atrial pressure

Umbilical venous pressure

Non-specific pressure label

Label

PA

UAP

FAP

LAP

ICP

LV

Description

Pulmonary artery pressure

Umbilical arterial pressure

Femoral arterial pressure

Left atrial pressure

Intracranial pressure

Left ventricular pressure

NOTE

The same label cannot be selected for different pressures. When two pressures are detected having the same label, the monitor automatically changes one pressure label to a currently unused one.

13.6.3

Setting the Pressure Type for Display

For the non-specific pressure (P1, P2, P3 or P4), the displayed pressure type is configurable. To set the displayed pressure type, follow this procedure:

1.

Select the numeric area or waveform area of the non-specific pressure to enter the corresponding pressure dialog.

2.

Select the Setup tab.

3.

Set Measure :

◆ If this non-specific pressure is arterial pressure, set the Measure to All . In this case, its corresponding numeric area displays systolic pressure, diastolic pressure and mean pressure.

If this non-specific pressure is venous pressure, set the Measure to Mean Only . In this case, its corresponding numeric area displays only the mean pressure.

13.6.4

Changing the Sensitivity

The IBP value displayed on the monitor screen is the average of data collected within a specific time. The shorter the averaging time is, the quicker the monitor responds to changes in the patient’s blood pressure, and the higher the sensitivity. Contrarily, the longer the averaging time is, the slower the monitor responds to changes in the patient’s blood pressure, the lower the sensitivity, but the measurement accuracy will be improved. For critically ill patients, selecting higher sensitivity will help with understanding the patient’s state.

To set the sensitivity, follow this procedure:

1.

Select the IBP numeric area or waveform area to enter the corresponding pressure dialog.

2.

Select the Setup tab.

3.

Set Sensitivity .

13.6.5

Setting the IBP Waveform

To set the IBP waveform, follow this procedure:

1.

Select the IBP numeric area or waveform area to enter the corresponding pressure dialog.

2.

Select the Setup tab.

3.

Set the following properties of the IBP waveform:

◆ Speed

◆ Scale : if Auto is selected, the size of the pressure’s waveform will be adjusted automatically.

13 - 6 BeneVision N1 Patient Monitor Operator’s Manual

13.6.6

Setting the Display Format of Artery Pressure

To set the display format of the artery pressure, follow this procedure:

1.

Select the numeric area or waveform area of any arterial pressure to enter the corresponding menu.

2.

Select the Setup tab.

3.

Set Display Format .

13.6.7

Showing/Hiding the Alarm Limits of Artery Pressure

To set whether to display the alarm limits of the arterial pressure, follow this procedure:

1.

Select the numeric area or waveform area of any arterial pressure to enter the corresponding menu.

2.

Select the Setup tab.

3.

Switch on or off Display Alarm Limits.

13.6.8

Setting the Use PA-D as PAWP Switch (only available when the N1 is used with the independent external display)

The PA-D value can be configured to replace the PAWP value for hemodynamic calculation. To do so, follow this procedure:

1.

Select the PA numeric area or waveform area to enter the PA dialog.

2.

Select the Setup tab.

3.

Switch on or off Use PA-D as PAWP .

For more information on hemodynamic calculation, see 17.4 Hemodynamic Calculations

.

13.6.9

Enabling PPV Measurement

PPV indicates pulse pressure variation. When measuring the arterial pressure (except PA), the PPV measurement is available. To enable the PPV measurement, follow this procedure:

1.

Select the IBP numeric area or waveform area to enter the corresponding pressure dialog.

2.

Select the PPV Setup tab.

3.

Switch on PPV Measure .

You can select PPV source after enabling the PPV measurement.

WARNING

This monitor can calculate PPV from beat-to-beat values of any arterial pulsatile pressure. The circumstances under which the calculation of a PPV value is clinically meaningful, appropriate and reliable must be determined by a physician.

The clinical value of the derived PPV information must be determined by a physician. According to recent scientific literature, the clinical relevance of PPV information is restricted to sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia.

PPV calculation may lead to inaccurate values in the following situations:

◆ at respiration rates below 8 rpm

◆ during ventilation with tidal volumes lower than 8 ml/kg

◆ for patients with acute right ventricular dysfunction (cor pulmonale).

The PPV measurement has been validated only for adult patients.

13.7

PAWP (only available when the N1 is used with the independent external display)

Pulmonary Artery Wedge Pressure (PAWP) values, used to assess cardiac function, are affected by fluid status, myocardial contractility, and valve and pulmonary circulation integrity.

BeneVision N1 Patient Monitor Operator’s Manual 13 - 7

Obtain the measurement by introducing a balloon-tipped pulmonary artery flotation catheter into the pulmonary artery. When the catheter is in one of the smaller pulmonary arteries, the inflated balloon occludes the artery allowing the monitor to record changes in the intrathoracic pressures that occur throughout the respiration cycle.

The pulmonary wedge pressure is the left ventricular end diastolic pressure when the airway pressure and valve function are normal. The most accurate PAWP values are obtained at the end of the respiration cycle when the intrathoracic pressure is fairly constant and the artifact caused by respiration is minimal.

WARNING

PAWP monitoring is not intended for neonatal patients.

13.7.1

PAWP Equipment to Patient Connection

(2)

(1)

(3)

(4)

(6)

(7)

(8)

(5)

(1) IBP connector

(3) IBP transducer

(5) PA distal port

(7) Thermodilution catheter

(2) Flush bag

(4) Three-way valve

(6) Balloon inflation syringe

(8) Balloon

13.7.2

Preparing to Measure PAWP

To prepare to monitor PAWP, follow this procedure:

1.

Connect one end of the IBP cable to the IBP cable connector, and the other end to the IBP transducer. For more information, see

13.3.2 Measuring an Invasive Blood Pressure .

2.

Follow the manufacturer’s instructions to connect the PA port of the thermodilution catheter and the patient end of the IBP transducer.

3.

Zero the IBP transducer. For more information, see 13.3.3 Zeroing the IBP transducer

.

13 - 8 BeneVision N1 Patient Monitor Operator’s Manual

4.

Set the IBP label to PA

since the PAWP is measured on PA. For more information, see 13.6.2 Changing the

Pressure Label .

13.7.3

Measuring PAWP

To measure the PAWP, follow this procedure:

1.

Select the PA numeric area or waveform area to enter the PA dialog, and then select PAWP .

2.

Wedge the flotation catheter into the pulmonary artery by observing the PA waveform changes on the screen, referring to the following figure.

3.

Select Start .

4.

Inflate the balloon and pay attention to PA waveform changes on the screen when the prompt message

Ready For Balloon Deflation appears.

5.

Deflate the balloon when the prompt message Ready For Balloon Deflation appears. If the PA waveform is stable, but the monitor is still not showing the prompt message Ready For Balloon Deflation , select

Freeze to freeze the waveform, and deflate the balloon.

6.

Select Accept to save the PAWP value.

7.

If you need to start a new measurement, repeat step 3 to step 6.

BeneVision N1 Patient Monitor Operator’s Manual 13 - 9

If the measurement fails or you need to adjust the PAWP value, you can use the following buttons to adjust the

PAWP waveform and measurement.

Select the up or down arrow button to adjust the PAWP value.

Select the left or right arrow button to view the frozen waveforms of 40 seconds.

Select Accept to save the PAWP value.

WARNING

Prolonged inflation can cause pulmonary hemorrhage, infarction or both. Inflate the balloon for the minimum time necessary to get an accurate measurement.

If the PAWP is greater than the PA (systolic), deflate the balloon and report the incident in accordance with hospital policy. Because the pulmonary artery could be accidentally ruptured, and the PAWP value derived will not reflect the patient’s hemodynamic state, but will merely reflect the pressure in the catheter or balloon.

If the flotation/thermodilution catheter drifts into the wedge position without inflation of the balloon, the PA waveform assumes a wedged appearance. Take appropriate action, in accordance with standard procedures, to correct the situation.

NOTE

The PA alarm is turned off automatically when the monitor enters the PAWP screen.

13.7.4

Setting the Waveforms of the PAWP Screen

On the PAWP screen, select Setup to enter the PAWP Setup dialog. In the PAWP Setup dialog, you can make the following settings:

Select

Select

Select

Select

Reference Waveform 1

Reference Waveform 2

Speed

Scale to set an ECG lead wave as the first reference wave.

to set a respiration wave as the second reference wave.

to set a sweep speed for the displayed waveforms on the

to set the size of the PA waveform on the PAWP screen.

PAWP screen.

13.7.5

Performing Hemodynamic Calculation (only available when the N1 is used with the independent external display)

On the PAWP screen, select Hemo Calcs to enter the Calculations dialog. For more information, see

17.4 Hemodynamic Calculations .

13.8

IBP Troubleshooting

This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting service. If the problem persists, contact your service personnel.

NOTE

For the physiological and technical alarm messages, see Appendix

D Alarm Messages

.

13 - 10 BeneVision N1 Patient Monitor Operator’s Manual

Problem

Cannot see IBP numeric area or waveform area on the main screen

Cannot see systolic pressure and diastolic pressure for P1/P2/P3/P4

IBP readings seem unstable

Zeroing of IBP channel(s) fails.

Solution

1. Check that the IBP is set to display in the Screen Setup dialog. For more information, see.

3.9.2 Displaying Parameter Numerics and Waveforms .

2. Check that if the IBP parameter switch is enabled. If not, enable the IBP measurement. For more information, see

3.9.1 Switching On or Off a

Parameter

.

3. Check the connection of IBP cable, IBP transducer and module.

4. Check that the three-way valve is turned to the correct position.

5. Check that the IBP transducer has been zeroed. For more information, see

13.3.3 Zeroing the IBP transducer .

Set Measure to All in the P1/P2/P3/P4 setup page. For more information, see

13.6.3 Setting the Pressure Type for Display .

1. Make sure there are no air bubbles in the transducer systems.

2. Check that the transducer is properly fixed.

3. Zero the transducer again.

4. Replace the transducer.

1. Ensure that the channels are open to air.

2. Perform zero calibration again.

Do not sway the IBP transducer and tubing during zero calibration.

For more information, see 13.3.3 Zeroing the IBP transducer .

3. If zero calibration still fails, replace the transducer.

BeneVision N1 Patient Monitor Operator’s Manual 13 - 11

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13 - 12 BeneVision N1 Patient Monitor Operator’s Manual

14

Monitoring Carbon Dioxide (CO

2

)

14.1

CO

2

Introduction

CO

2

monitoring is a continuous, non-invasive technique for determining the concentration of CO

2

in the patient’s airway by measuring the absorption of infrared (IR) light of specific wavelengths. CO

2

has its own absorption characteristic and the amount of light passing the gas probe depends on the concentration of the measured CO

2

. When a specific band of IR light passes through respiratory gas samples, some of IR light will be absorbed by the CO

2

molecules. The amount of IR light transmitted after it has been passed through the respiratory gas sample is measured with a photodetector. From the amount of IR light measured, the concentration of CO

2

is calculated.

CO

2

measurement is used to monitor the patient’s respiratory status. The sidestream/Microstream CO

2 measurement takes a sample of the respiratory gas with a constant sample flow from the patient's airway and analyzes it with a remote CO

2

sensor built into the Sidestream or Microstream CO

2

module.

The sidestream and microstream CO

2

measurement can be used, with specified accessories, with intubated and non-intubated adult, pediatric, and neonatal patients. With intubated patients, a sample of the respiratory gas is drawn from the patient's breathing circuit through an airway adapter and a gas sampling line. With nonintubated patients, the gas sample is drawn through a nasal cannula.

Both sidestream and microstream CO

2

modules have the function of automatic barometric pressure compensation (the system automatically measures the barometric pressure to which the patient monitor is exposed).

CO

2

monitoring is intended for adult, pediatric and neonatal patients.

WARNING

The N1 monitor does not support CO

2

measurements when used for transporting patients by rotary or fixed-wing ambulance.

It is not recommended to measure O

2

when transporting a patient with the N1 monitor. Shaking the

CO

2

module during O

2

measurement may lead to a distorted O

2

waveform or inaccurate O

2 measurement.

14.2

Identifying CO

2

Modules

To measure CO

2

, use either the internal CO

2

module or the external CO

2

module. The external CO

2

module is connected to the N1 through the Modular Rack. For the connection of the N1 and the external CO

2

module, see

section 2.8.1 Installing the N1 or External Parameter Module into the Modular Rack .

In sequence from left to right, the following are sidestream CO

2

external module, microstream CO

2

external module, and N1 monitor with internal CO

2

module.

BeneVision N1 Patient Monitor Operator’s Manual 14 - 1

(1) (2)

(1) (2)

(6)

(3)

(4)

(5)

(4)

(1) CO

2

dialog hard key

(3) CO

2

watertrap seat

(5) Sample line connector

(2) CO

2

Measure/standby hard key

(4) Gas outlet

(6) Internal CO

2

adapter connector

14.3

CO

2

Safety Information

WARNING

Route all tubing away from the patient’s throat to avoid strangulation.

CAUTION

Remove the airway sample line from the patient’s airway while nebulized medications are being delivered. Measuring CO

2

during nebulization may lead to inaccurate CO

2

readings.

EtCO

2

values measured from the CO

2

module may differ from those from the blood gas analysis.

Avoid mechanical shock to the sidestream CO

2

module.

Shaking the CO2 module during O2 measurement may lead to a distorted O2 waveform or inaccurate O2 measurement

NOTE

The CO

2

module automatically suppresses physiological alarms until breathing waves have been detected. Ensure that the patient is properly connected when using the CO

2

module.

14.4

CO

2

Measurement Limitations

The following factors may influence the measurement accuracy:

Leaks or internal venting of sampled gas

Mechanical shock

Cyclic pressure up to 10 kPa (100 cmH

2

Other sources of interference, if any

O)

For more information, refer to A.14.8 CO

2

Specifications

.

CAUTION

Measurement accuracy of the sidestream CO

2

module may be affected by the breath rate and inspiration/expiration (I/E) ratio.

Measurement accuracy of the microstream CO

2

module may be affected by the breath rate.

14 - 2 BeneVision N1 Patient Monitor Operator’s Manual

14.5

CO

2

Display

The CO

2

numeric and waveform areas provide FiCO

2

measurement, EtCO

2

measurement, awRR measurement, and a CO

2

waveform.

(1) (2) (3) (4)

(1) CO

2

waveform

(3) End tidal CO

2

value (EtCO

2

)

(2) Fraction of inspired CO

2

(FiCO

2

)

(4) Airway respiration rate (awRR)

14.6

Measuring CO

2

Using the Sidestream/Microstream CO

2

Module

14.6.1

Preparing to Measure CO

2

Using the Sidestream CO

2

Module

To prepare the CO

2

measurement, follow this procedure:

1.

Select the appropriate gas sample line and watertrap according to the patient category.

2.

Connect one end of the gas sample line to the watertrap or to the CO

2

adapter.

If using the sidestream CO

2

module, connect the watertrap to the CO sample line to the watertrap.

2

module, and connect the gas

(1)

(2)

(3)

(1) Watertrap receptacle

(3) Gas sample line

(2) DRYLINE II watertrap

If using the N1 monitor for CO

2

measurement, connect one end of the gas sample line to the CO

2 adapter. Refer to the CO2 Adapter User Manual (PN: H-046-009994-00) for the connection of the CO

2 adapter and the gas sampling line.

BeneVision N1 Patient Monitor Operator’s Manual 14 - 3

(1)

(2)

(1) CO

2

adapter (2) Gas sample line

3.

Connect the other end of the gas sample line to the patient.

◆ For intubated patients requiring an airway adapter, install the airway adapter between the patient circuit and the ventilator Y-piece.

(1)

(2)

(3)

(4)

(1) Sample line

(3) Airway adapter

(2) Connection to the ventilator

(4) Connection to the patient

◆ For non-intubated patients, place the nasal cannula onto the patient.

14 - 4

4.

Connect the gas outlet to the scavenging system using an exhaust tube.

After the CO

2

module is connected, it enters measure mode by default and the monitor displays CO2 Starting .

CO

2

can be measured after the start-up sequence is complete.

WARNING

Do not use the adult or pediatric watertrap with a neonate patient. Otherwise, patient injury could result.

Connect the gas outlet to the scavenging system when measuring CO

2

using the sidestream CO

2 module.

CAUTION

Check the compatibility of the CO

2

adapter and the sampling line before use. The CO

2

adapter is intended for connecting the Oridion CO

2

sampling line.

BeneVision N1 Patient Monitor Operator’s Manual

Leakage in the breathing or sampling system may cause the displayed EtCO

2

values to be significantly low. Always make sure that all components are securely connected.

Inspect the airway adapter for a tight connection and proper operation before attaching it to the patient.

Squeezing or bending the sample line during sidestream or microstream CO

2

measurement may cause inaccurate CO

2

readings or no reading.

To avoid blocking the airway, empty the DRYLINE II watertrap container whenever half full.

Replacing the DRYLINE II watertrap once a month is recommended. Dispose of accumulated fluids in accordance with hospital policy or your local regulations.

The DRYLINE II watertrap has a filter preventing bacterium, water and secretions from entering the module. Extended use could destroy the filter in watertrap and fail to stop the bacterium, water and secretions entering the module, result in damaging the gas module and having infection risk.

NOTE

It is recommended to replace the CO

2

adapter at least once a year.

To extend the lifetime of the watertrap and module, disconnect the watertrap from the module and set the operating mode to Standby mode when CO

2

monitoring is not required.

The sample rates are different when different types of watertraps are used.

The emptying interval of the DRYLINE II adult/pediatric watertrap is 26 hours @ 120 ml/min, sample gas of 37 °C, room temperature of 23 °C, and 100% RH.

The emptying interval of the DRYLINE II neonatal watertrap is 35 hours @ 90 ml/min, sample gas of

37 °C, room temperature of 23 °C, and 100% RH.

14.6.2

Preparing to Measure CO

2

Using the Microstream CO

2

Module

To prepare the CO

2

module for measurement, follow this procedure:

1.

Connect one end of the sample line to the microstream CO

2

module.

(1)

(2)

(1) Sample line connector (2) Sample line

2.

Connect the other end of the sample line to the patient.

◆ For intubated patient requiring an airway adapter, install the airway adapter between the patient circuit and the ventilator Y-piece.

For non-intubated patient, place the nasal cannula onto the patient.

◆ For patient prone to mouth breathing, place the oral-nasal cannula onto the patient.

3.

Connect the gas outlet to the a scavenging system using an exhaust tube.

BeneVision N1 Patient Monitor Operator’s Manual 14 - 5

After the CO

2

module is connected, it enters measure mode by default and the monitor displays CO2 Sensor

Warmup . CO

2

can be measured after the start-up sequence is complete.

WARNING

Connect the gas outlet to the scavenging system when measuring CO

2

using the microstream CO

2 module.

NOTE

Disconnect the sample line from the module when CO

2

monitoring is not required.

14.6.3

Zeroing the Sidestream/Microstream CO

2

Module

The sidestream and microstream CO

2

modules perform a zero calibration automatically when needed. Once the zero calibration is started, the CO

2

module stops measuring and “ Zeroing ” is displayed in the CO

2

numeric area.

After the zero calibration is completed, the CO

2

module reacquires the CO

2

readings. During the reacquisition period, “ Zero Recovering ” is displayed in the CO

2

numeric area. Valid data will reappear 30 seconds after the zero calibration is started. You can hide the display of the “ Zero Recovering ” message, but values displayed during the reacquisition period may not be accurate. See

21.5.6 Hiding the Invalid Display after Zeroing the CO

2

Module for more information.

The automatic zero calibration will not start under the following conditions:

Physiological alarms related to CO

2

A zero RR alarm is active.

are active.

No breath has been detected for over 30 seconds.

You can also perform the zero calibration manually. For more information, see 21.5.5 Manually Zeroing the CO

2

Module .

14.7

Changing Settings for All CO

2

Modules

14.7.1

Changing CO

2

Alarm Settings

To change the CO

2

alarm settings, follow this procedure:

1.

Select the CO

2

numeric area or waveform area to enter the CO2 dialog.

2.

Select the Alarm tab.

3.

Enter the password if required. For more information, refer to 21.13.3 Selecting Password for User

Authentication

.

4.

Set alarm properties as desired.

14.7.2

Setting the CO

2

Waveform

To set the CO

2

waveform, follow this procedure:

1.

Select the CO

2

numeric area or waveform area to enter the CO2 dialog.

2.

Select the Setup tab.

3.

Set Waveform Type , Speed, Scale , or CO2 Scale of the CO

2

waveform.

14.7.3

Setting the RR Source

To set the respiration rate (RR) source, follow this procedure:

1.

Select the CO

2

numeric area or waveform area to enter the CO2 dialog.

2.

Select the Setup tab.

3.

Set RR Source .

14 - 6 BeneVision N1 Patient Monitor Operator’s Manual

When you select Auto , the system automatically selects the RR source according to the priority. The priority of

RR source is first CO

2

, and then ECG. When the current RR source does not have valid measurement, the system automatically switches the RR Source to Auto .

14.7.4

Entering the Standby Mode

Set the CO

2

module to one of the following modes according to the module status:

Select Measure mode when using the CO

2

module for monitoring.

Select Standby mode to prolong the CO

2

module service life when not using the CO

2

module.

The default operating mode is Measure . When not using the CO

2

module, proceed as follows to enter the

Standby mode:

1.

Select the CO

2

numeric area or waveform area to enter the CO2 dialog.

2.

Select the Setup tab.

3.

Set Operating Mode to Standby .

14.7.5

Entering the Intubation Mode

When performing intubation during general anesthesia, enter the intubation mode to reduce unnecessary alarms. To enter the intubation mode, follow this procedure:

1.

Select the CO

2

numeric area or waveform area to enter the CO2 dialog.

2.

Select Intubation Mode .

To exit the intubation mode, choose either of the following ways:

From the bottom of the CO2 dialog, select Exit Intubation Mode .

Select the Main Menu quick key

→ from the Alarm column select Exit Intubation Mode .

For the details of the intubation mode, see 6.11 Intubation Mode .

NOTE

When the configured intubation period is over, the monitor automatically exits the intubation mode and gives two alert sounds.

14.7.6

Setting the Auto Standby

The monitor enters standby mode automatically if no breath is detected after the configured period of time. To set the auto standby, follow this procedure:

1.

Select the CO

2

numeric area or waveform area to enter the CO2 dialog.

2.

Select the Setup tab.

3.

Set Auto Standby .

14.7.7

Setting Humidity Compensation

Sidestream and microstream CO

2

modules are configured to compensate CO

2

readings for either Body

Temperature and Pressure, Saturated Gas (BTPS), to account for humidity in the patient’s breath, or Ambient

Temperature and Pressure, Dry Gas (ATPD).

ATPD: P

CO2

(mmHg)=CO

2

(vol%) x P amb

/100

BTPS (sidestream): P

CO2

(mmHg)=CO

2

(vol%) x (P amb

- 47)/100

BTPS (microstream): P

CO2

(mmHg)=CO

2

(vol%) x (1- 0.03)x P amb

/100

Where, P

CO2

(mmHg)= partial pressure, vol%=CO

2

concentration, P amb

=ambient pressure, and unit is mmHg.

For the sidestream and microstream CO

2

module, set the humidity compensation on or off according to the actual condition.

To set the humidity compensation, follow this procedure:

1.

Select the CO

2

numeric area or waveform area to enter the CO2 dialog.

BeneVision N1 Patient Monitor Operator’s Manual 14 - 7

2.

Select the Setup tab.

3.

Set BTPS Compensation .

◆ Switch on for BTPS.

◆ Switch off for ATPD.

14.8

Setting the Gas Compensation

The presence of interfering gas affects the CO

2

measurement. To get the best possible measurement result, it is recommended to set the gas compensation. The configured concentration of the interfering gas should be in accordance with its actual proportion.

For the microstream CO

2

module, gas compensations are not required.

CAUTION

Make sure to use the appropriate compensations. Inappropriate compensations may cause inaccurate measurement values and result in misdiagnosis.

For the sidestream CO

2

module, follow this procedure to set the gas compensation:

1.

Select the CO

2

numeric area or waveform area to enter the CO2 dialog.

2.

Select the Setup tab.

3.

Set the compensation according to the actual condition.

14.9

Choosing a Time Interval for Peak-Picking

For microstream CO

2

modules, select a time interval for picking the highest CO

2

as the EtCO

2

and the lowest as the FiCO

2

.

To set the time interval, follow this procedure:

1.

Select the CO

2

numeric area or waveform area to enter the CO2 dialog.

2.

Select the Setup tab.

3.

Set Maximum Hold .

4.

Toggle between Single Breath , 10 s and 20 s .

Single Breath : EtCO

2

and FiCO

2

are calculated for every breath.

10 s and 20 s : EtCO

2

and FiCO

2

are calculated using 10 or 20 seconds of data.

14.10

Performing the Leakage Test

When measuring CO

2

using the internal CO

2

module or the external sidestream CO

2

module, the leakage test is required every time before the CO

2

measurement. To perform the CO

2

leakage test, follow this procedure:

1.

Connect the measuring accessories as per section 14.6.1 Preparing to Measure CO

2

Using the Sidestream CO

2

Module

.

2.

Wait until the startup finishes. Completely block the gas inlet on the sidestream CO

2

module or on the N1.

The alarm message “ CO2 Airway Occluded ” will appear on the screen.

3.

Continue to block the gas inlet for another one minute.

4.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

5.

Select the Module tab

CO2 tab.

6.

Check that the current flow rate is less than 10ml/min, and the alarm message “ CO2 Airway Occluded ” does not disappear.

This indicates that the module does not leak. If the alarm message disappears, or the flow rate is equal to

10ml/min or greater, it indicates that the module leaks. Perform the leakage test again. If the problem remains, contact your service personnel for help.

14 - 8 BeneVision N1 Patient Monitor Operator’s Manual

14.11

CO

2

Calibration

For sidestream and microstream CO

2

modules, a calibration is needed every year or when the measured values have a great deviation.

To calibrate the CO

2

module, contact your service personnel.

CAUTION

Connect the gas outlet to the scavenging system when calibrating the CO

2

module.

14.12

Test Method Used to Determine the Respiration Rate Measuring

Range

To determine the RR measurement range, follow this procedure:

1.

Connect the 5% CO

2

+ N

2

(BAL) gas cylinder, reduction valve, rhythm generator and gas sampling path of a monitor.

2.

Respectively set the rhythm generator to generate a respiration rate of 0 rpm, 6 rpm, 20 rpm, 60 rpm,

120rpm, and 150 rpm.

3.

Verify that it meets the specifications.

NOTE

The rhythm generator mentioned above is a sensor/sampling site in Figure 201.101 – Test apparatus for the TOTAL SYSTEM RESPONE TIME of an RGM of ISO 80601-2-55.

14.13

CO

2

Troubleshooting

This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting service. If the problem persists, contact your service personnel.

NOTE

For the physiological and technical alarm messages, see Appendix D Alarm Messages .

14.13.1

Troubleshooting the Sidestream/Microstream CO

2

Module

Problem

EtCO

2

measurements too low

Solution

1. Check the patient status.

2. Check the sample line and connectors for leakage.

3. Ventilate the room if the environmental CO

2

concentration is too high.

14.14

Oridion Information

Oridion Patents

This posting serves as notice under 35 U.S.C.§287(a) for Covidien patents: http://www.covidien.com/patents.

BeneVision N1 Patient Monitor Operator’s Manual 14 - 9

No Implied License

Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized CO

2 sampling consumables which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device and/or CO2 sampling consumable.

14 - 10 BeneVision N1 Patient Monitor Operator’s Manual

15

Review

15.1

Review Overview

Trends are patient data collected over time and displayed in graphic, tabular, or other forms to give you a picture of how the patient's condition is developing. The Review dialog also enables access to review the events, 12lead ECG analysis results and waveforms, full disclosure waveforms, and so on.

15.2

Review Dialog

The Review dialog contains tabs to display trend data in tabular, graphic, or other forms.

15.2.1

Accessing the Review Dialog

To enter the review dialog, select the Main Menu quick key → from the Review column select the desired option.

15.2.2

Example Review Dialog

The review pages have a common structure. The graphic trends review page is taken as an example:

(1)

(2)

(5)

(6)

(7)

(3)

(4)

(8)

(9)

(1)

(2)

(3)

(4)

Event type indicator: different color blocks match different types of events:

■ Red: high priority alarm event

Yellow: medium priority alarm event

Cyan: low priority alarm event

Green: manual event

White: operation-related event

Current screen time line: indicates the time length of the current screen.

Waveform area: displays trend curves. The color of trend curves is consistent with the color of parameter labels.

Time line: indicates the entire time length.

■ : indicates the time length of trend data.

: indicates the time length of no trend data.

can be moved within this time length.

cannot be moved within this time length.

Different color blocks along the time line indicate events of different types. See the color definition for the event type indicator.

BeneVision N1 Patient Monitor Operator’s Manual 15 - 1

(5)

(6)

(7)

(8)

(9)

Event area: displays the event of the cursor time. Selecting the event accesses the event list. If there is no event at the cursor time, the cursor time is displayed.

Cursor: this is adjusted by touching different locations. Adjusting this changes the data displayed in the Event area and Numeric area.

Numeric area: displays numeric values at the cursor indicated time. The background color of numeric values matches the alarm priority.

Slider: indicates the position of current screen time in the entire time length. Dragging this button left or right enables you to locate the trend data at a specific time and also refreshes trend data in current screen accordingly.

Button area.

15.2.3

Symbols on Review Pages

The following table lists the symbols on review pages.

Symbol

or

Description

Slider: indicates the position of current screen time in the entire time length. Dragging the slider left or right enables you to locate the trend data at a specific time and also refreshes data in current screen accordingly.

Goes to the previous or next event.

Event list: displays events in a chronological order. The most recent event is displayed at the top. The number of asterisk symbols before an event indicates alarm priority.

Print button: select it to output patient information and data through the printer.

15.2.4

Common Operations

This section describes common operations for all review pages.

15.2.4.1

Browsing Trend Data

Browse trend data in one of the following ways:

Move the cursor.

Move the slider .

Slide your finger on the screen.

15.2.4.2

Viewing Events

You can view the following types of events:

Manually triggered events

Parameter-related operation events and alarm-related events, such as starting NIBP measurement

Operation events not related to parameters, such as system time change

View events in either of the following ways:

Select

Select

and select the desired event.

or to jump to the previous event or next event.

Events are displayed in a chronological order. The most recent event is displayed at the top. The number of asterisk symbols before an event indicates alarm priority as follows:

***: high priority alarm

**: medium priority alarm

*: low priority alarm

15 - 2 BeneVision N1 Patient Monitor Operator’s Manual

15.2.5

Tabular Trends Review Page

The tabular trends review page displays trend data in a tabular form.

15.2.5.1

Entering the Tabular Trends Review Page

To enter the tabular trends review page, select the Main Menu quick key

from the Review column select

Tabular Trends .

15.2.5.2

Changing the Tabular Trend Group

To change the tabular trend group, follow this procedure:

1.

Enter the tabular trends review page.

2.

Set Trend Group .

15.2.5.3

Editing the Tabular Trend Group

The setting of the Trend Group defines the contents of displayed trends. It is possible to edit any trend group except for the All and Standard trend groups. To do so, follow this procedure:

1.

Enter the tabular trends review page:

2.

Select Group Setup → select the desired tab.

◆ Rename the trend group (optional): select the desired name.

symbol at the upper left corner and input the

Add parameters: select desired parameters from the Choices column, and then select Add . Selecting

Add All adds all parameters (up to the maximum of 83).

◆ Delete parameters: select desired parameters from the Selected column, and then select Delete .

Selecting Delete All deletes all parameters except for HR.

Move the position of parameters displayed on the trend page: select desired parameters from the

Selected column, and then select Move up , Move Down , Move to Top , or Move to Bottom .

◆ Display two parameters side by side: select two parameters from the Selected column, and then select Overlap . Then, the symbol appears at the right of the overlapped parameters. The overlapped parameters will be displayed side by side in one numerics area and waveform area.

◆ Unoverlap two parameters: select the overlapped parameters from the Selected column, and then select Unoverlap .

Selecting Default will restore the trend group settings to factory defaults.

NOTE

Trend groups labeled All or Standard cannot be edited.

The HR parameter and waveform are always displayed in the first row on the trend page. It cannot be deleted or moved.

15.2.5.4

Changing the Resolution of Tabular Trend Data

The interval of tabular trends defines the interval of displaying trend data. A short interval is especially suited for neonatal applications, where the clinical situation may change very quickly. In adult monitoring, where the patient's status typically changes more gradually, a longer interval may be more informative.

To change the interval of trend data, follow this procedure:

1.

Enter the tabular trends review page.

2.

Select Interval .

5 sec or 30 sec : select to view up to 4 hours of tabular trends at an interval of 5 seconds or 30 seconds.

1 min, 5 min, 10 min, 15 min, 30 min, 1 hr, 2 hrs, or 3 hrs : select to view up to 120 hours of tabular trends at selected interval.

◆ Select parameters, such as NIBP, or GCS, to view the tabular trends when these parameter measurements are acquired.

BeneVision N1 Patient Monitor Operator’s Manual 15 - 3

NOTE

Changing between intervals does not typically change the position of the slider or cursor except to round it to the nearest interval, however changing intervals to be 30 seconds or less will move any cursor position more than 4 hours ago to the oldest data less than 4 hours ago.

15.2.5.5

Printing a Tabular Trends Report

To print a tabular trends report, follow this procedure:

1.

Enter the tabular trends review page.

2.

Select to enter the Print Setup dialog.

3.

Set the tabular trends report as described in 18.6.3 Configuring Tabular Trends Reports .

4.

Select Print or Print (All) .

◆ Print : the trend data before the above set Time , for the above set Period , and at the above set

Interval will be printed.

Print (All) : all the stored trend data will be printed at the review interval.

15.2.6

Graphics Trends Review Page

The graphic trends review page displays trend data in a visual format.

15.2.6.1

Entering the Graphic Trends Review Page

To enter the graphic trends review page, select the Main Menu quick key

→ from the Review column select

Graphic Trends .

15.2.6.2

Changing the Graphic Trend Group

To change the graphic trend group, follow this procedure:

1.

Enter the graphic trends review page.

2.

Select and set Trend Group .

15.2.6.3

Editing the Graphic Trend Group

1.

Enter the graphic trends review page.

2.

Select and select Group Setup.

For more information, see

15.2.5.3 Editing the Tabular Trend Group

for detail on how to edit the group.

15.2.6.4

Changing the Resolution of Trend Data

To change the length of trend data displayed on the current screen, follow this procedure:

1.

Enter the graphic trends review page.

2.

Select Zoom .

8 min: the screen displays eight minutes of trend data. You can view the most recent one hour of data.

◆ 30 min, 1 hr, 2 hrs, 4 hrs : the screen displays 30 minutes, one hour, two hours, or four hours of trend data. You can view the most recent four hours of data.

8 hrs, 12 hrs, 24 hrs, 48 hrs : the screen displays 8 hours, 12 hours, 24 hours, or 48 hours of trend data.

You can view the most recent 120 hours of data.

15.2.6.5

Changing the Number of Waveforms

To change the number of waveforms displayed on the trend review page, follow this procedure:

1.

Enter the graphic trends review page.

2.

Select and set Trend Group .

15 - 4 BeneVision N1 Patient Monitor Operator’s Manual

15.2.6.6

Printing a Graphic Trends Report

To print a graphic trends report, follow this procedure:

1.

Enter the graphic trends review page.

2.

Select to enter the Print Setup dialog.

3.

Set the graphic trends report as described in

18.6.4 Configuring Graphic Trends Reports

.

4.

Select Print to print the graphic trend data before the above set Time and for the above set Period .

15.2.7

Events Review Page

The monitor stores events in real time, including technical alarm events, physiological alarm events, manual events, and operational events. When an event occurs, all the measurement numerics and three event-related waveforms 16 seconds before and after the event are stored.

NOTE

Alarms are saved as events and will be maintained if the equipment is powered down. The time of equipment power down is not recorded as an event and cannot be reviewed.

Earlier events will be overwritten by later ones if the storage capacity is reached.

A total loss of power does not affect the events already stored.

15.2.7.1

Entering the Events Review Page

To enter the events review page, select the Main Menu quick key

→ from the Review column select Events .

The Event page displays the event list. Events are displayed in descending chronological order, with the most recent displayed at the top. The number of asterisk symbols before an event indicate alarm priority as described

in 6.3.3 Alarm Indicators

.

Different color blocks are displayed on the left of each event to indicate different event types.

Red: high priority alarm event

Yellow: medium priority alarm event

Cyan: low priority alarm event

Green: manual event

White: operation-related event

The number of currently selected events and the total number of events are displayed at the top right corner of the event list. For example, 2/4 indicates that the selected event is the second event in the filtered events and the total number of filtered events is 4. Total indicates the total number of events. For example: Total : 28 means that there are a total of 28 events.

15.2.7.2

Configuring the Filter

You can filter events to facilitate event review. To configure the filter, follow this procedure:

1.

Enter the Events page.

2.

Select Filter . From the drop-down list, select the desired filter item.

You can create up to two sets of custom filter. To do so, follow this procedure:

1.

From the Filter drop-down list, select Custom 1 or Custom 2 to enter the Filter Setup menu.

2.

Select the Name field to edit the name of the custom filter criterion.

3.

Select the desired items.

If you want to review events which happened around certain time, select the button → set the time → select Ok

.

The cursor then jumps to the event happened closest to the time entered.

15.2.7.3

Editing Events

To edit events, follow this procedure:

1.

Enter the Events page and tick off the desired events.

BeneVision N1 Patient Monitor Operator’s Manual 15 - 5

2.

Select to edit the selected events.

◆ Lock : manually lock the event. Locked events cannot be deleted.

◆ Note : enter comments for the event.

◆ Rename : allow renaming an event name. Only manual events and arrhythmia events can be renamed if enabled by the hospital’s settings.

15.2.7.4

Viewing Event Details

To view waveforms and parameter values at the event time, follow this procedure:

1.

Enter the Events page.

2.

Select Detail .

To display beat labels on the first ECG waveform, switch on Beat Anno . The white beat labels indicate heart beats classification and may explain suspected, missed, or false arrhythmia calls. Heart beats are classified as follows:

N = Normal

V = Ventricular ectopic

S = Supraventricular premature

P = Paced

L = Learning

? = Insufficient information to classify beat

I = Inoperative (for example, Lead Off )

M = Missed beat

If you switch on Beat Anno on the Events page, beat labels will also be displayed on the Full Disclosure page, and vise versa. Beat labels can be printed out.

15.2.7.5

Printing Event Reports

To print event reports via a printer, follow this procedure:

1.

Enter the events review page.

2.

Select to enter the Print Setup dialog.

3.

Select the desired options.

◆ Print All Event List : print the entire event list.

◆ Print List of Selected Events : print the list of selected events.

◆ Print Detail of Selected Events : print the details of selected events.

◆ Print Displayed Event Detail : print the waveforms and parameters of the currently displayed event.

4.

Select Print .

15.2.8

Full Disclosure Review Page

You can review up to 48 hours of waveform data on the full disclosure review page. You can view both the compressed waveforms and numeric values.

15.2.8.1

Entering the Full Disclosure Review Page

To enter the full disclosure review page, select the Main Menu quick key

→ from the Review column select Full

Disclosure .

15.2.8.2

Selecting Waveforms

You can select the waveforms to be displayed and stored. Up to 48 hours of waveforms for all parameters can be stored. When closing the Select Waveform dialog, a prompt will inform you of the duration of waveforms that can be saved if the amount is less than 48 hours. To save and display the desired waveforms, follow this procedure:

15 - 6 BeneVision N1 Patient Monitor Operator’s Manual

1.

Enter the full disclosure review page.

2.

Select and select Setup to enter the Select Waveform page.

3.

Select the Storage tab and set the desired waveforms to be stored in the monitor. Select the Display

(Maximum: 3) tab and set the desired waveforms to be displayed on the Full Disclosure page.

NOTE

Storing more waveforms may shorten the storage time to less than 48 hours. Please adjust the waveforms stored with this consideration.

Parameter labels from external devices are prefixed with the plus sign (+).

In case of alarms, the background of the compressed waveform is highlighted with a colored block during the alarm time:

Red: high alarm priority

Yellow: medium alarm priority

Cyan: low alarm priority

15.2.8.3

Setting the Scale and Duration

To set the length and size of displayed compressed waveforms, follow this procedure:

1.

Enter the full disclosure review page.

2.

Select Overview . If there is no Overview button in the Full disclosure page, skip this step.

3.

Set the waveforms scale in either of the following ways:

Select the Scale button. If you do not see Scale , select the

Select the waveform label.

4.

Select Duration to set the length of displayed waveforms.

button to show it.

5.

Select the parameter label beside the waveforms to set scale for each parameter.

15.2.8.4

Viewing Details of Compressed Waveforms

To view the full waveforms and numeric values, follow this procedure:

1.

Enter the full disclosure review page.

2.

Select Detail .

You can perform the following operations on the this page:

Switch on Beat Anno . For more information, see

15.2.7.4 Viewing Event Details

.

Select and , ECG Gain , or Save As Event .

Select Overview to switch to the compressed waveform view.

15.2.8.5

Printing the Full Disclosure Waveform Report

To print a compressed waveform report, follow this procedure:

1.

Enter the full disclosure review page.

2.

Select to enter the Print Setup dialog.

3.

Select waveform type you want to print:

◆ Print Waveform Overview : compressed waveform of selected period will be printed. This option is only available when printing from the Overview or compressed waveform view.

Print Displayed Waveform Detail : parameter values and all stored waveforms around the cursor time will be printed. This option is only available when printing from the Detail view.

4.

Select Print .

BeneVision N1 Patient Monitor Operator’s Manual 15 - 7

NOTE

When a parameter label is prefixed with the plus sign (+) on a printout, it indicates that the data is from an external device.

15.2.9

OxyCRG Review Page (available when the N1 is used with the independent external display)

You can review up to 48 hours worth of 4 minute trend curves on the OxyCRG review page. The OxyCRG review functionality is available for neonatal monitoring only.

NOTE

OxyCRG Review Page is available only when Patient Category is set to Neo.

15.2.9.1

Entering the OxyCRG Review Page

Choose one of the following methods to enter the OxyCRG review page:

From the OxyCRG screen, select the ABD events list area.

Select the Main Menu quick key → from the Review column select OxyCRG .

15.2.9.2

The Display of the OxyCRG Review Page

The following figure shows the OxyCRG screen:

(1)

(2) (2)

(3)

(1) Event title area: displays information of the selected event, such as the event type and time.

(2) Event detail area: displays 4 minutes of parameter trends and compressed waveform, and parameter values of the selected event.

(3) Event summary area: displays ABD events within the Zoom period. The selected event is enclosed in a white frame.

(4) Event statistics area: displays the total number of ABD events and the numbers of each event within the Zoom period.

15.2.9.3

Changing the Resolution of Trend Curves

To set the resolution of trend curves, follow this procedure:

1.

Enter the OxyCRG review page.

2.

Set Zoom .

(4)

15 - 8 BeneVision N1 Patient Monitor Operator’s Manual

NOTE

If the Zoom is set for a large duration (for example, 8 hrs), the screen may show "No Patient Data" for the first several minutes of data collection (for example, 6 minutes), but data will be shown after enough data has been collected.

15.2.9.4

Printing an OxyCRG Review Report

To print an OxyCRG review report, follow this procedure:

1.

Enter the OxyCRG review page.

2.

Select to enter the Print Setup dialog.

3.

Select Print . The report duration corresponds to the duration of data shown on the screen.

15.2.10

12-Lead ECG Review Page

When 12-lead ECG analysis is performed, you can review the most recent 20 events of 12-lead analysis. For more information, see

8 Resting 12-Lead ECG Analysis

.

15.2.10.1 Entering the 12-Lead Review Page

Choose one of the following methods to enter the 12-lead ECG review page:

Upon completion of 12-lead ECG analysis, select Review from the 12-Lead Interpretation page. For more

information, see 8 Resting 12-Lead ECG Analysis .

Select the Main Menu quick key → from the Review column select 12-Lead ECG .

15.2.10.2 Switching to Median Complex (for Glasgow Algorithm Only)

The median complex template displays 12-lead ECG waveforms on one page in 4 columns, with 3 lines in each column, and one rhythm lead waveform at the bottom. Additionally, a short vertical bar appears above each waveform, marking the start and end positions of the P-wave and the QRS-wave and the end position of T-wave.

To view Median Complex, follow this procedure:

1.

Enter the 12-lead review page.

2.

Select Median Complex .

Selecting Waveform can return to the 12-lead ECG waveform page.

15.2.10.3 Setting 12-Lead ECG Waveforms

To set the 12-lead ECG waveforms on the review page, follow this procedure:

1.

Enter the 12-lead review page.

2.

Set Speed , Gain , and Layout .

15.2.10.4 Printing the 12-Lead ECG Report

To print the 12-Lead ECG report, follow this procedure:

1.

Enter the 12-lead review page.

2.

Select .

3.

Configure the 12-lead ECG report.

4.

Select Print .

15.3

Reviewing Discharged Patients

For discharged patients, you can review the trend data in the review page. You can also review the events and

12-lead ECG analysis results.

BeneVision N1 Patient Monitor Operator’s Manual 15 - 9

15.3.1

Checking the Data of a Discharged Patient

1.

Access the Discharged Patients dialog box by selecting the Main Menu quick key

→ from the Patient

Management column select Discharged Patients .

2.

From the patient list select the desired patient.

3.

Select Detail .

15.3.2

Checking the Information of a Discharged Patient

1.

Access the data of the discharged patient as described in

15.3.1 Checking the Data of a Discharged Patient

.

2.

Select the icon to enter the Patient Management dialog box.

3.

Select Ok to exit the Patient Management dialog box.

15 - 10 BeneVision N1 Patient Monitor Operator’s Manual

16

Clinical Assistive Applications (CAA) (available when the N1 is used with the independent external display)

The Clinical Assistive Applications (CAA) function integrates some commonly used clinical guidelines and tools into the monitor. It puts the currently monitoring parameter measurements together and provides comprehensive analysis results.

CAA can improve the clinician’s working efficiency. However, it is not directly used for diagnosis and cannot not replace the clinician’s judgement.

16.1

Checking Software Licenses

Licenses are required to run the following CAA functions in the monitor:

■ Early Warning Score (EWS)

■ SepsisSight

To check the licenses, select the Main Menu quick key → select License → Local .

To install the licenses, follow this procedure:

1.

Connect the N1 to the Dock.

2.

Connect the USB drive to the Dock’s USB connector.

3.

Select the Main Menu quick key → select License → select External .

4.

Select Install .

16.2

Early Warning Score (EWS)

The Early Warning Scores (EWS) can help you recognize the early sign of deterioration in patients based on vital signs and clinical observations. It is based on the “Royal College of Physicians (2015) National Early Warning

Score (NEWS2): Standardizing the assessment of acute illness severity in the NHS, Report of a Working Party. RCP,

London. Depending on the score calculated, appropriate recommendations are displayed.

The monitor supports the following scores:

MEWS (Modified Early Warning Score)

NEWS (National Early Warning Score)

NEWS2 (National Early Warning Score 2)

Custom Score

A subscore is given for each parameter based on the measured or entered value. When all the required parameters are entered or measured, the subscores are added together to calculate the total early warning score. Each subscore has a color coding to indicate associated level of risk. When the total score is outside of the thresholds, actions are recommended. MEWS, NEWS and NEWS2 can give total scores.

Custom Score is based on user-defined parameters.

MEWS, NEWS and NEWS2 are intended for adult patients only. The patient category applied to the Custom Score is defined by the Mindray Clinical Score Configuration Tool. For more information, see Mindray Clinical Scoring

Config Tool Instruction for Use (P/N: 046-012986-00).

WARNING

EWS is not intended for pediatric and neonatal patients

The EWS scores and recommended actions are for reference only and cannot be directly used for diagnostic interpretation.

BeneVision N1 Patient Monitor Operator’s Manual 16 - 1

EWS cannot be used as an prognosis index. It is not a clinical judgement tool. Clinicians must use their clinical judgement in conjunction with the EWS tool at all times.

MEWS and NEWS are intended for adult patients only. NEWS is not applicable to pregnant woman and COPD (Chronic Obstructive Pulmonary Disease) patients.

NOTE

The EWS scores does not trigger any alarms and cannot used for continuous monitoring.

16.2.1

Displaying the EWS Numerics Area

To display the EWS numerics area, follow this procedure:

1.

Access Tile Layout in either of the following ways:

◆ Select the Screen Setup quick key → select the Tile Layout tab.

◆ Select the Main Menu quick key → from the Display column select Tile Layout .

2.

Select the parameter area where you want to display the EWS score, and then from the popup list select

EWS .

(2)

(1)

(3)

(8)

(4)

(5)

(6)

(5)

(6)

(7

(8)

(1)

(2)

(3)

(4)

(7)

EWS protocol label

Scoring countdown: time to the next scoring.

Scoring interval

The scoring time

Single parameter whose score reaches 3

Risk level indicator. The level of risk increases from top down. The current level is enclosed by a white square frame.

History total score. The rightmost one is the latest history score.

Total score. The color of the circle indicates the level of risk.

16.2.2

Accessing the EWS Screen

Access the EWS window in any of the following ways:

Select the EWS parameter area

Select the EWS quick key.

Select the Screen Setup quick key → select the Choose Screen tab → select EWS .

Select the Main Menu quick key → from the CAA column select EWS .

When the EWS screen is hidden as

EWS screen.

, you can also choose one of the following methods to quickly enter the

Swipe left or right across the touchscreen with two fingers until you switch to the EWS screen.

Swipe right across the touchscreen with a single finger ,

16 - 2 BeneVision N1 Patient Monitor Operator’s Manual

■ Select the button ,

Take NEWS2 as an example, the EWS screen is shown as follows. Your screen may be slightly different due to the configuration.

(12) (11) (10) (9)

(1)

(2)

(8)

(7)

(6)

(3)

(4)

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

(10)

(11)

(12)

(5)

Total score. The color of the circle indicates the level of risk.

Risk level indicator. The level of risk increases from top down. The current level is enclosed by a white frame.

Parameter area: display the subscore and parameter value of each parameter. The keyboard symbol indicates that the parameter value is manually entered.

History total scores area: selecting this area or swiping up with one finger can review the trends of total score and each subscore

Selecting this button expands the History Total Scores area where your can review the trends of the total score and each subscore.

Selecting this button or swiping right across the screen with one finger displays the trends of total score and parameter values for scoring.

Clinician ID (displays only when the Clinician ID is enabled): allows inputing the Clinician ID to associate with the

EWS score. For more information, see

21.4.1 Enabling Inputing the Clinician ID .

Select this button to see the clinical response to the current score

Scoring interval

EWS protocol label

Scoring countdown: time to the next scoring.

The scoring time

16.2.3

Performing EWS Scoring

To perform scoring, follow this procedure:

1.

Select Reset to clear the previous score and update values of currently monitored parameters and relevant subscores.

BeneVision N1 Patient Monitor Operator’s Manual 16 - 3

2.

For NEWS2, set the SpO2 Scale .

◆ Scale 1 : for patient without hypercapnic respiratory failure.

◆ Scale 2 : f or patients with a prescribed oxygen saturation requirement of 88–92% (for example, in patients with hypercapnic respiratory failure).

3.

Measure or manually enter other required parameters and observations.

4.

If the clinician ID is enabled, input the clinician information by selecting and manually entering the information, or by scanning the clinician’s barcode.

5.

Select Calculate to get the total score.

6.

If Score Confirmation is enabled, select Confirm to save current scoring, or select Cancel to give up

current scoring. Refer to section 16.2.4.2 Setting the Scoring Confirmation Switch for more information.

CAUTION

The decision to use Scale 2 of the SpO2 Scale should be made by a competent clinical decision maker and should be recorded in the patient’s clinical notes.

NOTE

Before calculating the score, select Reset to clear the previous score.

The keyboard symbol at the right of the parameter value indicates that the value is manually entered.

You can get the score only when all required parameters have been measured or entered.

16.2.4

Changing EWS Settings

16.2.4.1

Changing the Scoring Protocol

The monitor is configured with a default scoring protocol. To change the scoring protocol, follow this procedure:

1.

From the EWS page select Setup .

2.

Set Score .

16.2.4.2

Setting the Scoring Confirmation Switch

To select if confirmation is required before saving score, follow this procedure:

1.

From the EWS page select Setup .

2.

Set Score Confirmation switch.

◆ Off: the monitor automatically saves the scoring result after the scoring is completed.

◆ On: you need to confirm that whether the scoring result is saved or not after the scoring is completed.

16.2.4.3

Setting the Manual Data Timeout

The manually input parameter data can be configured to become invalid after a preset time. To set the timeout period for the input data, follow this procedure:

1.

From the EWS screen select Setup .

2.

From the Manual Data Timeout area, select a desired parameter and set its timeout period.

NOTE

If the data is expired and not updated, the monitor displays the corresponding parameter score in outline font, and gives a timeout alarm.

16.2.4.4

Setting Auto Scoring

The monitor automatically starts scoring at the preset interval. To set auto scoring, follow this procedure:

16 - 4 BeneVision N1 Patient Monitor Operator’s Manual

1.

From the EWS page select Setup .

2.

Set Auto Scoring :

◆ Interval : the monitor automatically starts scoring at the preset interval.

◆ NIBP : the monitor automatically starts scoring at the completion of each NIBP measurement.

◆ Alarm : the monitor automatically starts scoring when an alarm occurs to the parameter for scoring.

◆ If no option is selected, the monitor does not initiate auto scoring.

16.2.4.5

Setting Auto Scoring Interval

1.

From the EWS page select Setup .

2.

Set Interval :

◆ By Score : the monitor automatically starts scoring as per the interval selected for corresponding total score.

5 min - 24 h : If Auto Scoring is set to Interval , the monitor automatically starts scoring as per the selected interval. If Auto Scoring is not set to Interval , the countdown timer of manual scoring is selected.

16.2.5

Viewing Historical Scores

From the EWS screen, you can view the total score or subscores of the past 24 hours. To do so, choose either of the following ways:

Select the history total score area.

From the history total score area, swipe up with a finger.

To return to the EWS screen, select

from the top of the historical score screen. Refer to 16.2.2 Accessing the

EWS Screen 

for the position of the history total score area.

16.2.6

Viewing Parameter Trends

From the EWS screen, you can view the 24-hour graphic trends of each parameter used for scoring. To do so, choose either of the following ways:

Select the button.

Swipe right across the EWS screen with a finger.

From the screen of parameter trends, selecting the button or swiping left across the screen with a finger can return to the EWS screen.

Refer to 16.2.2 Accessing the EWS Screen 

for the position of the button.

16.3

Glasgow Coma Scale (GCS)

The Glasgow Coma Scale (GCS) function is based on Teasdale’s Assessment of Coma and Impaired Consciousness-A

Practical Scale (Lancet, 1974) . Three aspects of behavior are independently measured: eye opening, verbal response, and motor response. The scores are added together to indicate that patient’s level of consciousness.

GCS is intended for adults and pediatric patients.

CAUTION

GCS is intended as an adjunct in patient assessment and must be used in conjunction with observation of clinical signs and symptoms.

GCS is not applied to patients that are sedated, muscularly relaxed, with artificial airway, drunk, hypothermia or in status epilepsies.

Please refer to hospital policy regarding acceptable use of GCS.

When applied to children younger than five years old or to the elderly, the GCS score may not reflect actual function.

BeneVision N1 Patient Monitor Operator’s Manual 16 - 5

16.3.1

Displaying the GCS Parameter Area

To display the GCS parameter area, follow this procedure:

1.

Access Tile Layout in either of the following ways:

◆ Select the Screen Setup quick key

select the Tile Layout tab.

Select the Main Menu quick key

→ from the Display column select Tile Layout .

2.

Select the parameter area where you want to display the GCS score, and then from the popup list select

GCS .

The following figure shows the GCS parameter area. The display may be configured to look slightly different.

(4)

(1)

(5)

(2)

(3)

(1)

(2)

(3)

(4)

(5)

(6)

GCS label

Total score and level of consciousness. The color of the circle indicates the level of risk.

Scoring time

Scoring countdown: time to the next scoring

Scoring interval

Subscores

E: eye opening

◆ V: verbal response

M: motor response

(6)

16.3.2

Accessing the GCS Dialog

Enter the GCS dialog in any of the following ways:

Select the GCS parameter area.

Select the GCS quick key.

Select the Main Menu quick key

→ from the CAA column select GCS .

16 - 6 BeneVision N1 Patient Monitor Operator’s Manual

(1)

(2)

(1) Subscore (2) Total score

16.3.3

Performing GCS Scoring

To perform scoring, follow this procedure:

1.

From the Eye Opening area, Verbal Response area, and Motor Response area, respectively select an item that represents the patient’s status.

2.

Select Ok to accept the total score.

The following table lists the default score range and color of relevant consciousness level.

Level

Mild damage

Moderate damage

Severe damage

Range

13-15

9 - 12

3 - 8

Color

White

Yellow

Red

NOTE

The GCS score range is adjustable. Refer to

21.4.4 Setting GCS Threshold for Each Consciousness Level

for the method of changing the high limit and low limit of each consciousness level.

16.3.4

Setting GCS Scoring Interval

From the GCS dialog, select Interval to set GCS scoring interval. When the scoring interval is reached and you do not perform another scoring, the score will be invalidated and displayed as outline fonts.

16.3.5

Reviewing GCS Trend Data

From the GCS dialog, select Review to enter the Review dialog and view the GCS trend data from the Tabular

Trends .

16.4

SepsisSight

TM

The SepsisSight

TM

function is based on Third International Consensus Definitions for Sepsis and Septic Shock

(Sepsis-3) and Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock:

2016 (SSC Guideline 2016). It assists you in recognizing the early signs and symptoms of sepsis by comparing the state of the patient to the defined criteria and then guides you through the recommended treatment protocol.

BeneVision N1 Patient Monitor Operator’s Manual 16 - 7

CAUTION

SepsisSight is not a diagnostic or therapeutic tool and is not intended to replace the competent judgment of a clinician.

SepsisSight should not be used with intravenous immunoglobulins in adult patients with severe sepsis or septic shock.

SepsisSight should not be used with intravenous selenium for the treatment of severe sepsis.

SepsisSight should not be used with sodium bicarbonate therapy for the purpose of improving hemodynamics or reducing vasopressor requirements in patients with hypoperfusion-induced lactic acidemia with pH ≥7.15.

NOTE

SepsisSight is intended to perform routine screening of potentially infected seriously ill patients for severe sepsis to allow earlier implementation of therapy.

SepsisSight is intended to be followed by application of hospital–based performance improvement efforts in severe sepsis.

The Surviving Sepsis Campaign recommends to discuss goals of care and prognosis with patients and families.

The Surviving Sepsis Campaign recommends to incorporate goals of care into treatment and end-oflife care planning, utilizing palliative care principles where appropriate.

The SepsisSight goals of care are intended to be applied in a time defined by the SSC guidelines.

Due to space limitations on the screen, the recommendations cannot always be reproduced in the full detail available in the printed and on-line guidelines.

SepsisSight is intended for patients suffering from sepsis or suspicion of sepsis.

16.4.1

Accessing the SepsisSight Dialog

Enter the SepsisSight dialog in any of the following ways:

Select the SepsisSight quick key.

Select the Main Menu quick key → from the CAA column select SepsisSight .

16.4.2

Screening

As per Sepsis-3, SepsisSight supports quick Sepsis-Related Organ Failure Assessment (qSOFA, or quick SOFA) and

Sepsis-Related Organ Failure Assessment (SOFA).

16.4.2.1

Performing qSOFA qSOFA evaluates the patient’s respiration rate, systolic blood pressure and altered mental status.

RR and BP-S being monitored are automatically obtained. You can also manually enter these values by selecting the symbol. Select whether the patient’s mental status is altered. Then qSOFA score is calculated.

If the qSOFA score is greater than or equal to 2, or sepsis is suspected, select SOFA>> to perform SOFA.

To clear the score, select Reset .

NOTE

The keyboard symbol indicates that the parameter value is manually entered.

The question mark (?) in the score circle indicates that more parameter values are required before a score can be calculated.

16.4.2.2

Performing SOFA

SOFA score is used to identify organ function or the rate of sepsis-related organ failure.

16 - 8 BeneVision N1 Patient Monitor Operator’s Manual

To perform SOFA, enter the value or select a range for each item, SOFA score will be automatically calculated.

To clear the score, select Reset .

If Sepsis criteria is met, make a comprehensive judgement on the clinical features.

16.4.2.3

Changing Screening Settings

From the Screening page select Setup . You can change the following settings:

In the Screening area, set RR (rpm) high limit and BP-S (mmHg) low limit for qSOFA scoring.

In the Unit area, set the unit of Bilirubin and Creatinine .

16.4.3

Recommendations

As per the SSC Guidelines 2016, SepsisSight provides graded recommendations. Pages Part I and Part II in the

SepsisSight screen list these recommendations.

16.4.3.1

Viewing Detailed Recommendations

Select the icon at the right side of each item to view detailed recommendations of SSC Guideline

2016. The star symbol

indicates the grade of recommendation:

★★

: strong recommendation

: weak recommendation

No

★ symbol: ungraded strong recommendation

16.4.3.2

Marking Implemented Items

Check off implemented items. Then the time and date are automatically recorded and displayed.

You can select the symbol to change the date and time.

Select Reset to clear the current results.

16.4.4

Reviewing SepsisSight Trend Data

Select the Graphic Trends tab to view the trend of parameters of resuscitation.

When a recommended treatment is checked off on the Part I page and Part II page, relevant event is marked in the tabular trend. Vertical lines of different colors indicate the event type:

White: inspection performed

Blue: medication

Green: goal achieved

Purple: other treatment

BeneVision N1 Patient Monitor Operator’s Manual 16 - 9

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16 - 10 BeneVision N1 Patient Monitor Operator’s Manual

17

Calculation (only available when the N1 is used with the independent external display)

17.1

Calculation Overview

The monitor provides calculation functions. The calculated values, which are not directly measured, are computed based on the values you provide. The calculation function is independent of other monitoring functions and can therefore be used for patients being monitored by other monitors. Any operation in a calculation dialog does not affect the patient monitored by the current monitor.

You can perform the following calculations:

Drug calculations

Hemodynamic calculations

Oxygenation calculations

Ventilation calculations

Renal calculations

17.2

Calculation Safety Information

WARNING

Decisions on the choice and dosage of drugs administered to patients must always be made by the physician in charge. The drug calculations are based on the values input; it does not check the plausibility of the calculation performed.

Check that the entered values are correct and the calculated values are appropriate. Mindray assumes no responsibility for any consequences caused by wrong entries and improper operations.

17.3

Drug Calculations

17.3.1

Performing Drug Calculations

To perform drug calculations, follow this procedure:

1.

Access the drug calculator by either of the following ways:

◆ Select the Calculations quick key → select the Drug tab.

◆ Select the Main Menu quick key → from the Calculations column select Drug .

2.

Set Drug Name and Patient Category.

If the dose of drug is weight dependent, you must input the patient’s weight. The dose calculation program has a library of commonly used drugs, while Drug A through Drug E are user defined.

3.

Enter the known values, for example Drug Amount and Solution Volume.

4.

Select Calculate . The calculated values are indicated by red arrows.

NOTE

If available, the patient category and weight from the Patient Demographics dialog are automatically entered when you first access drug calculation. You can change the patient category and weight. This will not change the patient category and weight stored in the patient demographic information.

BeneVision N1 Patient Monitor Operator’s Manual 17 - 1

17.3.2

Checking the Titration Table

The titration table shows information on the currently used drugs. Use the titration table to see what dose of a drug your patient will receive at different infusion rates. To access the titration table, follow this procedure:

1.

Access drug calculator by either of the following ways:

◆ Select the Calculations quick key.

◆ Select the Main Menu quick key → from the Calculations column select Drug .

2.

Select the Titration Table tab.

3.

Select Dose Type to set the type of dose unit in the titration table.

4.

Select Interval to set the interval between two adjacent titration table items.

You can select how to display the titration table:

Dose : the titration table is listed in the sequence of increased drug dose.

Infusion Rate : the titration table is listed in the sequence of increased infusion rate. By default the resolution of the infusion rate is one (1). By selecting Exact Rate the resolution of the infusion rate can reach 0.01 so that you can display the infusion rate more accurately.

17.3.3

Drug Calculation Formula

Description

Dose

Dose (weight based)

Drug Amount

Drug Amount (weight based)

Duration

Duration (weight based)

Concentration

Solution volume

Infusion rate

Infusion rate (weight based)

Unit Formula

Dose/hr

Dose/min

Dose/kg/hr

Dose/kg/min g series: mcg, mg, g unit series: Unit, KU, MU mEq series: mEq g series: mcg, mg, g unit series: Unit, KU, MU mEq series: mEq hr hr mcg/ml, mg/ml, g/ml, Unit/ml,

KU/ml, MU/ml, mEq/ml ml ml/hr g•ml/hr

Dose = Infusion Rate × Concentration

Dose (weight based) = Infusion Rate ×

Concentration/Weight

Drug Amount =Dose × Duration

Drug Amount (weight based) = Dose × Duration ×

Weight

Duration = Amount/Dose

Duration (weight based) = Amount/(Dose × Weight)

Concentration = Drug Amount/Solution Volume

Volume = Infusion Rate × Duration

Infusion Rate = Dose/Concentration

Infusion Rate = Dose × Weight/Concentration

17.3.4

Titration Table Calculation Formula

Description

Infusion Rate

Infusion Rate (weight based)

Dose

Dose (weight based)

Unit ml/hr ml/hr

Dose/hr

Dose/min

Dose/kg/hr

Dose/kg/min

Formula

Infusion Rate = Dose/Concentration

Infusion Rate = Weight × Dose/Concentration

Dose = Infusion Rate × Concentration

Dose (weight based) = Infusion Rate ×

Concentration/Weight

17 - 2 BeneVision N1 Patient Monitor Operator’s Manual

17.4

Hemodynamic Calculations

The monitor provides the hemodynamic calculation function and can save the results of up to 10 calculations, which are displayed in groups.

17.4.1

Performing Hemodynamic Calculations

To perform hemodynamic calculation, follow this procedure:

1.

Access hemodynamic calculation by either of the following ways:

◆ Select the Calculations quick key → Hemodynamics tab.

◆ Select the Main Menu quick key → from the Calculations column select Hemodynamics .

2.

Enter the known values. For a patient who is being monitored, the currently measured values are automatically entered.

3.

Select Calculate .

A calculated value greater than the normal upper limit is indicated by an up arrow “ ↑ ”. A calculated value lower than the normal lower limit is indicated by a down arrow “

”.

You can select Range to show the normal range of each parameter.

17.4.2

Input Parameters for Hemodynamic Calculations

Input Parameter cardiac output heart rate pulmonary artery wedge pressure mean arterial pressure pulmonary artery mean pressure central venous pressure end-diastolic volume height weight

Label

C.O.

HR

PAWP

MAP

PA-M

CVP

EDV

Height

Weight

Unit

L/min bpm mmHg mmHg mmHg mmHg ml cm kg

NOTE

If you enable Use PA-D as PAWP, PA-D value will be used to replace PAWP value for hemodynamic

calculation. For more information, refer to 13.6.8 Setting the Use PA-D as PAWP Switch (only available when the N1 is used with the independent external display) .

17.4.3

Calculated Parameters and Formulas for Hemodynamic Calculations

Calculated Parameters cardiac index body surface area

Label

C.I.

BSA stroke volume stroke index systemic vascular resistance

SV

SVI

SVR

Unit

L/min/m

2 m

2 ml ml/m

2

DS/cm

5

Formula

C.I. (L/min/m

2

) = C.O. (L/min)/BSA (m

2

)

BSA (m

2

) = Wt

0.425

(kg) × Ht

0.725

(cm) ×

0.007184

SV (ml) = 1000× C.O. (L/min)/HR (bpm)

SVI (ml/m

2

) = SV (ml)/BSA (m

2

)

SVR (DS/cm

5

) = 79.96 × [APMAP (mmHg) -

CVP (mmHg)]/C.O. (L/min)

BeneVision N1 Patient Monitor Operator’s Manual 17 - 3

Calculated Parameters systemic vascular resistance index pulmonary vascular resistance pulmonary vascular resistance index left cardiac work

Label

SVRI

PVR

PVRI

LCW left cardiac work index left ventricular stroke work left ventricular stroke work index right cardiac work

LCWI

LVSW

LVSWI

RCW right cardiac work index right ventricular stroke work right ventricular stroke work index

RCWI

RVSW

RVSWI ejection fraction end-diastolic volume index

EF

EDVI end-systolic volume ESV end-systolic volume index ESVI

Unit

DS•m

2

/cm

5

DS/cm

5

DS•m

2

/cm

5 kg•m kg•m/m

2 g•m g•m/m

2 kg•m kg•m/m

2 g•m g•m/m

2

% ml/m2 ml ml/m

2

Formula

SVRI (DS•m

2

/cm

5

) = SVR (DS/cm

5

) × BSA (m

2

)

PVR (DS/cm

5

) = 79.96 × [PAMAP (mmHg) -

PAWP (mmHg)]/C.O. (L/min)

PVRI (DS•m

2

/cm

5

) = PVR (DS/cm

5

) × BSA (m

2

)

LCW (kg•m) = 0.0136 × APMAP (mmHg) × C.O.

(L/min)

LCWI (kg•m/m

2

) = LCW (kg•m)/BSA (m

2

)

LVSW (g•m) = 0.0136 × APMAP (mmHg) × SV

(ml)

LVSWI (g•m/m

2

) = LVSW (g.m)/BSA (m

2

)

R CW (kg•m) = 0.0136 × PAMAP (mmHg) × C.O.

(L/min)

R CWI (kg•m/m

2

) = RCW (kg.m)/BSA (m

2

)

R VSW (g•m) = 0.0136 × PAMAP (mmHg) × SV

(ml)

R VSWI (g•m/m

2

) = RVSW (g•m)/BSA (m

2

)

EF (%) = 100 × SV (ml)/EDV (ml)

EDVI (ml/m

2

) = EDV (ml)/BSA (m

2

)

ESV (ml) = EDV (ml) –SV (ml)

ESVI (ml/m

2

) = ESV (ml)/BSA (m

2

)

17.5

Oxygenation Calculations

The monitor provides the oxygenation calculation function and can save the results of up to 10 calculations, which are displayed in groups.

17.5.1

Performing Oxygenation Calculations

To perform oxygenation calculations, follow this procedure:

1.

Access oxygenation calculation by either of the following ways:

◆ Select the Calculations quick key

Oxygenation tab.

◆ Select the Main Menu quick key

from the Calculations column select Oxygenation .

2.

Enter the known values. For a patient who is being monitored, the currently measured values are automatically entered.

3.

Select Calculate .

A calculated value greater than the normal upper limit is indicated by an up arrow “

”. A calculated value lower than the normal lower limit is indicated by a down arrow “ ↓ ”.

In the Oxygenation page, you can also perform the following operations:

Select OxyCont Unit , Hb Unit , and Pressure Unit . Then corresponding parameter values will be automatically converted and updated accordingly.

Select Range to show the normal range of each parameter.

17 - 4 BeneVision N1 Patient Monitor Operator’s Manual

17.5.2

Input Parameters for Oxygenation Calculations

Input Parameter cardiac output percentage fraction of inspired oxygen partial pressure of oxygen in the arteries partial pressure of carbon dioxide in the arteries arterial oxygen saturation partial pressure of oxygen in venous blood venous oxygen saturation hemoglobin respiratory quotient atmospheric pressure height weight

Label

C.O.

FiO

2

PaO

2

PaCO

2

SaO

2

PvO

2

SvO

2

Hb

RQ

ATMP

Height

Weight

17.5.3

Calculated Parameters and Formulas for Oxygenation Calculations

Unit

L/min

% mmHg, kPa mmHg, kPa

% mmHg, kPa

% g/L, g/dl, mmol/L

None mmHg, kPa cm, inch kg, lb

Calculated Parameters body surface area

Label

BSA alveolar-arterial oxygen difference capillary oxygen content

AaDO

2

CcO

2 venous admixture QS/QT

Unit m

2 oxygen consumption arterial oxygen content venous oxygen content

VO

2

ml/min

CaO

2 ml/L, ml/dL

CvO

2 ml/L, ml/dL arteriovenous oxygen content difference oxygen extraction ratio oxygen transport partial pressure of oxygen in the alveoli

C(a-v)O

2

O

2

ER

DO

2

PAO

2 ml/L, ml/dl

% ml/min mmHg, kPa mmHg, kPa ml/L, ml/dl

% oxygen transport index oxygen consumption

DO

2

I

VO

2

I ml/min/m

2 ml/min/m

2

Formula

BSA (m

2

) = Wt

0.425

(kg) × Ht

0.725

(cm) ×

0.007184

VO

2

(ml/min) = C(a-v)O

2

(ml/L)× C.O. (L/min))

CaO

2

(ml/L) = 10× (0.0134 × Hb (g/dl) × SaO

2

(%)) +0.031× PaO

2

(mmHg)

CvO

2

(ml/L) = 10× (0.0134 × Hb (g/dl) × SvO

2

(%)) +0.031 × PvO

2

(mmHg)

C(a-v)O

2

(ml/L) = CaO

2

(ml/L) - CvO

2

(ml/L)

O

2

ER (%) = 100×C(a-v)O

2

(ml/L)/CaO

2

(ml/L)

DO

2

(ml/min) = C.O. (L/min) × CaO

2

(ml/L)

PAO

2

(mmHg) = [ATMP (mmHg) - 47 mmHg] ×

FiO

2

(%)/100 - PaCO

2

(mmHg) × [FiO

2

(%)/100

+ (1 - FiO

2

(%)/100)/RQ]

AaDO

2

(mmHg) = PAO

2

(mmHg) - PaO

2

(mmHg)

CcO

2

(ml/L) = Hb (g/L) × 1.34 + 0.031 × PAO

2

(mmHg)

QS/QT (%) = 100× [1.34 × Hb (g/L) × (1 - SaO2

(%)/100) + 0.031 × (PAO2 (mmHg) - PaO2

(mmHg))]/[1.34 × Hb (g/L) × (1 - SvO2 (%)/

100) + 0.031× (PAO2 (mmHg) - PvO2

(mmHg))]

DO2I (ml/min/m

2

) = CaO2 (ml/L) × (C.O. (L/ min)/BSA (m

2

))

VO2I (ml/min/m

2

) = C (a-v) O2 (ml/L) ×(C.O. (L/ min)/BSA (m

2

))

BeneVision N1 Patient Monitor Operator’s Manual 17 - 5

17.6

Ventilation Calculations

The monitor provides the ventilation calculation function and can save the results of up to 10 calculations, which are displayed in groups.

17.6.1

Performing Ventilation Calculations

To perform ventilation calculations, follow this procedure:

1.

Access ventilation calculation by either of the following ways:

◆ Select the Calculations quick key → Ventilation tab.

◆ Select the Main Menu quick key → from the Calculations column select Ventilation .

2.

Enter the known values. For a patient who is being monitored, the currently measured values are automatically taken. If the anesthesia machine or ventilator is connected, measured values for ventilation calculation are also automatically entered.

3.

Select Calculate .

A calculated value greater than the normal upper limit is indicated by an up arrow “ ↑ ”. A calculated value lower than the normal lower limit is indicated by a down arrow “

”.

On the Ventilation page, you can also perform the following operations:

Select Pressure Unit . Then corresponding parameter values will be automatically converted and updated accordingly.

Select Range to show the normal range of each parameter.

17.6.2

Input Parameters for Ventilation Calculations

Input Parameter percentage fraction of inspired oxygen respiration rate partial pressure of mixed expiratory CO2 partial pressure of carbon dioxide in the arteries partial pressure of oxygen in the arteries tidal volume respiratory quotient atmospheric pressure

Label

FiO

2

RR

PeCO

2

PaCO

2

PaO

2

TV

RQ

ATMP

17.6.3

Calculated Parameters and Formulas for Ventilation Calculations

Unit

% rpm mmHg, kPa mmHg, kPa mmHg, kPa ml

None mmHg, kPa

Calculated Parameters Label partial pressure of oxygen in the alveoli

PAO

2 alveolar-arterial oxygen difference oxygenation ratio

AaDO

2

Pa/FiO

2 arterial to alveolar oxygen ratio minute volume a/AO

2

MV

Unit mmHg, kPa mmHg, kPa mmHg, kPa

%

L/min

Formula

PAO

2

(mmHg) = [ATMP (mmHg) - 47 mmHg] ×

FiO

2

(%)/100 - PaCO

2

(mmHg) × [FiO

2

(%)/100

+ (1 - FiO

2

(%)/100)/RQ]

AaDO

2

(mmHg) = PAO

2

(mmHg) - PaO

2

(mmHg)

Pa/FiO

2

(mmHg) = 100 × PaO

2

(mmHg)/FiO

2

(%) a/AO

2

(%) = 100 × PaO

2

(mmHg)/PAO

2

(mmHg)

MV (L/min) = [TV (ml) × RR (rpm)]/1000

17 - 6 BeneVision N1 Patient Monitor Operator’s Manual

Calculated Parameters Label volume of physiological dead space physiologic dead space in percent of tidal volume alveolar volume

Vd

Vd/Vt

VA

Unit ml

%

L/min

Formula

Vd (ml) = TV (ml) × [1 - PeCO

2

(mmHg)/PaCO

2

(mmHg)]

Vd/Vt (%) = 100 × Vd (ml)/TV (ml)

VA (L/min) =[TV (ml) - Vd (ml)] × RR (rpm)/

1000

17.7

Renal Calculations

The monitor provides the renal calculation function and can save the results of up to 10 calculations, which are displayed in groups.

17.7.1

Performing Renal Calculations

To perform renal calculations, follow this procedure:

1.

Access renal calculation by either of the following ways:

◆ Select the Calculations quick key

select the Renal tab.

◆ Select the Main Menu quick key

from the Calculations column select Renal .

2.

Enter the known values.

3.

Select Calculate .

A calculated value greater than the normal upper limit is indicated by an up arrow “

”. A calculated value lower than the normal lower limit is indicated by a down arrow “ ↓ ”.

You can select Range to show the normal range of each parameter.

17.7.2

Calculated Parameters and Formulas for Renal Calculations

Input Parameter urine potassium urinary sodium urine plasm osmolality urine osmolality serum sodium creatinine urine creatinine blood urea nitrogen height weight

Label

URK

URNa

Urine

Posm

Uosm

SerNa

Cr

UCr

BUN

Height

Weight

Unit mmol/L mmol/L ml/24 hrs mOsm/kgH

2

O mOsm/kgH

2

O mmol/L

μmol/L

μmol/L mmol/L cm kg

BeneVision N1 Patient Monitor Operator’s Manual 17 - 7

17.7.3

Calculated Parameters and Formulas for Renal Calculations

Calculated Parameters urine sodium excretion

Label

URNaEx urine potassium excretion URKEx sodium potassium ratio Na/K clearance of sodium fractional excretion of sodium osmolar clearance

CNa creatinine clearance rate Clcr

FENa

Cosm free water clearance CH2O urine to plasma osmolality ratio blood urea nitrogen creatinine ratio urine-serum creatinine ratio

U/P osm

BUN/Cr*

U/Cr

*: BUN/Cr is a ratio under the unit of mol.

Unit mmol/24 hrs mmol/24 hrs

% ml/24 hrs ml/min

% ml/min ml/hr

None

Mmol/L

Formula

URNaEx (mmol/24 hrs) = Urine (ml/24 hrs) ×

URNa (mmol/L)/1000

URKEx (mmol/24 hrs) = Urine (ml/24 hrs) ×

URK (mmol/L)/1000

Na/K (%) = 100 × URNa (mmol/L)/URK (mmol/

L)

CNa (ml/24 hrs) = URNa (mmol/L) × Urine (ml/

24 hrs)/SerNa (mmol/L)

Clcr (ml/min) = Ucr (μmol/L) × Urine (ml/24 hrs)/[Cr (μmol/L) × (BSA (m

2

)/1.73) × 1440]

FENa (%) = 100 × URNa (mmol/L) × Cr (μmol/

L)/[SerNa (mmol/L) × Ucr (μmol/L)]

Cosm (ml/min) = Uosm (mOsm/kgH

2

O) ×

Urine (ml/24 hrs)/(Posm (mOsm/kgH

2

O) ×

1440)

CH2O (ml/hr) = Urine (ml/24 hrs) × [1 - Uosm

(mOsm/kgH

2

O)/Posm (mOsm/kgH

2

O)]/24

U/P osm = Uosm (mOsm/kgH

2

O)/Posm

(mOsm/kgH

2

O)

BUN/Cr = 1000 × BUN (mmol/L)/Cr (μmol/L)

17 - 8 BeneVision N1 Patient Monitor Operator’s Manual

18

Printing

18.1

Supported Printer

The monitor can output patient reports via a connected network printer. The monitor supports the following printers:

HP LaserJet Pro M202dw

HP LaserJet Pro 400 M401n

HP LaserJet P4015n

HP LaserJet 600 M602

HP LaserJet Enterprise M605

HP LaserJet Enterprise M608n

NOTE

For more details about the printer, refer to the document accompanying the printer. With product upgrades, the monitor may support additional printers without prior notice. If you have any doubts about the compatibility of the printer used with this monitor, contact Mindray.

18.2

End Case Reports

18.2.1

Printing the End Case Report

To print the end case report, choose one of the following ways:

Select Print from the End Case Report menu.

Select Print End Case Report when you discharge a patient.

Select the End Case Report quick key (only available when the N1 is used with the independent external display).

18.2.2

Setting a Report as An End Case Report

The following reports can be set as end case reports:

Tabular Trends Report

Graphic Trends Report

Event Report

12-lead Interpretation

Alarm Limits Report

Realtime Report

ECG Report

To set a report as an end case report, follow this procedure:

1.

Select the Main Menu quick key → from the Report column select End Case Report .

2.

From the Select Reports page, select the desired report tab, for example ECG Report .

18.2.3

Configuring the End Case Reports

To configure the end case reports, follow this procedure:

1.

Select the Main Menu quick key

→ from the Report column select End Case Report .

BeneVision N1 Patient Monitor Operator’s Manual 18 - 1

2.

From the Report Setup page, set the following end case reports:

◆ Select the Tabular Trends Report , Graphic Trends Report , Realtime Report , and ECG Report tab, and set these end case report by referring to section

18.6 Configuring Reports .

◆ Select the Event Report tab, and select the event that needs to be printed.

◆ Select the 12-Lead Interpretation tab, and set the switch of Median Complex , Measurements ,

Interpretation , or Interpretation Summary . For other settings, refer to section

18.6.1 Configuring

ECG Reports .

18.2.4

Setting the End Case Report Period

To set the end case report print period, follow this procedure:

1.

Select the Main Menu quick key → from the Report column select End Case Report .

2.

From the Select Reports page, set the Period .

NOTE

End case report print period is calculated from the patient discharged time to the configured period.

Period setting is applicable to all of the end case reports.

18.3

Manually Starting a Printing Task

This section describes different methods for manually printing a report.

18.3.1

Printing from the Screen

The button will be shown at the top of dialogs that have associated reports. If the button is gray, then there is not enough information to begin the report, or the printer has not been set up.

When the icon is white, pressing it opens a Print Setup dialog or starts printing a report. If the Print Setup dialog is entered, configure the report and press Print to start printing.

18.3.2

Printing Realtime Reports

Select the Print quick key to print a realtime report. You can also print a realtime report from the Report Setup

dialog. For more information, see 18.3.3 Printing Most Common Reports .

18.3.3

Printing Most Common Reports

The following most common reports can be printed:

ECG Report

Realtime Report

Tabular Trends Report

Graphic Trend Report.

To print these reports, follow this procedure:

1.

Select the Main Menu quick key

→ from the Report column select Report Setup .

2.

Select the desired report tab.

3.

Check the settings.

4.

Select Print .

18.4

Automatically Printing Reports

When a parameter alarm switch is set to on and an alarm is triggered for this parameter, you can set the monitor to automatically print a Print on Alarm Report.

To do so, follow this procedure:

18 - 2 BeneVision N1 Patient Monitor Operator’s Manual

1.

Access alarm related tabs such as the Alarm tab for a parameter in one of the following ways:

◆ Select the parameter or waveform area of the desired parameter → select the Alarm tab.

◆ Select the Main Menu quick key → from the Parameters column select Setup → select the desired parameter

select the Alarm tab.

2.

Switch on Alarm Outputs for desired parameters.

18.5

Stopping a Printing Task

To stop a printing task, follow this procedure:

1.

Select the Main Menu quick key → from the Report column select Print Queue .

2.

Select desired printing tasks and then select Delete . Alternately, select Delete All to stop all the printing tasks.

18.6

Configuring Reports

This section focuses on how to configure ECG reports, realtime reports, tabular trends reports, and graphic trends reports.

18.6.1 Configuring ECG Reports

To configure ECG reports, follow this procedure:

1.

Select the Main Menu quick key → from the Report column select Report Setup .

2.

Select the ECG Report tab.

3.

Set the desired options.

The following table explains some of the less familiar options.

Menu item

Speed

Auto Interval

12-Lead Format

Rhythm Lead 1

Rhythm Lead 2

Rhythm Lead 3

Format Sequence

Function Description

Set the print speed of

ECG waveforms

25 mm/sec : prints 25 mm of ECG waveform per second.

50 mm/sec : prints 50 mm of ECG waveform per second.

Defines the spacing between the ECG waveforms on a printout

On: automatically adjusts the space between waveforms to avoid overlapping.

Off : each waveform area has the same size on a printout.

Note: Auto Interval is only enabled when 12×1 is selected for 12-Lead Format .

Select the format of 12lead ECG waveforms on a printout.

12×1: displays 12-lead ECG waveforms on one page in one column.

6×2 : displays 12-lead ECG waveforms on one page in two columns, with 6 lines in each column.

6×2+1 : displays 12-lead ECG waveforms on one page in two columns, with 6 lines in each column, and one rhythm lead waveform at the bottom.

3×4+1 : displays 12-lead ECG waveforms on one page in 4 columns, with 3 lines in each column, and one rhythm lead waveform at the bottom.

3×4+3 : displays 12-lead ECG waveforms on one page in 4 columns, with 3 lines in each column, and three rhythm lead waveforms at the bottom.

Select the lead that will be used as Rhythm

Lead 1, 2, or 3.

I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6

Note: Rhythm Lead setting is only enabled when 6×2+1 , 3×4+1 , or 3×4+3 is selected for

12-Lead Format .

Select the recording method of ECG report generated by auto measurement

Sequential : 12-lead ECG data are recorded sequentially and displayed in 3 lines and 4 columns with 2.5 seconds of ECG data for each column.

Simultaneous : Record simultaneous 12-lead ECG data.

BeneVision N1 Patient Monitor Operator’s Manual 18 - 3

NOTE

When ECG Lead Set is set to 3-Lead, the ECG report cannot be printed.

18.6.2

Configuring Realtime Reports

To configure tabular realtime reports, follow this procedure:

1.

Select the Main Menu quick key → from the Report column select Report Setup .

1.

Select the Realtime Report tab.

2.

Set the desired options.

The following table explains some of the options.

Menu item

Select Waveform

Function

Select the desired waveform to print

Description

Current Waveforms : prints the realtime report for the currently displayed waveforms and all the currently measured parameter values.

Selected Waveforms : prints the realtime report for the waveforms configured in the Select Waveform dialog, accessed by clicking the

Select Waveform button.

18.6.3

Configuring Tabular Trends Reports

To configure tabular trends reports, follow this procedure:

1.

Select the Main Menu quick key

→ from the Report column select Report Setup .

2.

Select the Tabular Trends Report tab.

3.

Set the desired options.

The following table explains some of the options.

Menu Item

Time

Period

Interval

Report Format

Function Description

Select the time before which a tabular trends report will be printed

Select the period during which a tabular trends report will be printed.

/

Select the resolution of the tabular trends printed on a report.

Select the printing principle.

Auto : one page of a tabular trends before the current time will be printed at the selected Interval .

All : all stored tabular trends will be printed at the selected

Interval .

30 min to 96 hrs : 30 min to 96 hrs of tabular trends before the selected Time will be printed at the selected Interval .

NIBP, EWS , GCS : at an interval of acquiring the values of selected parameter (EWS and GCS are only available when the N1 is used with the independent external display).

Auto : using the Interval setting of the Tabular Trends review page.

5 sec to 3 hrs : the tabular trends will be printed at the interval of 5 sec to 3 hrs .

Parameter Oriented : print one page span of report with parameters listed by row and time listed by column when

Interval is set to Auto .

Time Oriented : print one page span of report with time listed by row and parameter listed by column when Interval is set to Auto .

Note that Interval on Auto only limits the number of rows or columns for Time. The report may have multiple pages to accommodate the number of parameters. To limit the parameters, change the Trend Group .

18 - 4 BeneVision N1 Patient Monitor Operator’s Manual

18.6.4

Configuring Graphic Trends Reports

To set graphic trends reports, follow this procedure:

1.

Select the Main Menu quick key

→ from the Report column select Report Setup .

2.

Select the Graphic Trends Report tab.

3.

Set the desired options.

Menu Item

Period

Function

Select the period during which a graphic trends report will be printed.

Description

Auto : one page of a graphic trends before the current time will be printed.

All : all stored graphic rends will be printed..

30 min to 96 hrs : 30 min to 96 hrs of graphic trends before the selected Time will be printed.

18.7

Viewing Printer Status

You can view the status of the most recent ten printing tasks in the Print Queue dialog. To view the status of printing tasks, follow this procedure:

1.

Select the Main Menu quick key

→ from the Report column select Print Queue .

2.

View the status of printing tasks in the Print Queue dialog.

Each printing task includes the following information:

Print time

Report title

Printer name (when using the printer server) or IP address (when using the network printer)

Printing status, for example, printing, failed, retrying, and waiting.

18.8

Printer Out of Paper

When the printer runs out of paper, the print request will remain incomplete. If there are too many print jobs that remain incomplete, then a printer error may occur. To resolve the error, install paper. Some print requests may be lost if the incomplete tasks overflow the printer buffer. Missing or lost reports must be recreated and printed.

To reduce risks of printer errors, maintain enough paper in the printer.

18.9

List of Reports

The monitor can output the following reports to the printer:

■ Realtime reports

◆ Realtime Report

◆ Freeze Report

◆ ECG Report (5-lead, 6-lead , 12-lead)

◆ 12-Lead Interpretation Report (realtime)

◆ Print on Alarm Report

◆ Alarm Limits Report

◆ Titration Table Report (only available when the N1 is used with the independent external display)

◆ Hemodynamic Calculation Report (only available when the N1 is used with the independent external display)

◆ Oxygenation Calculation Report (only available when the N1 is used with the independent external display)

◆ Ventilation Calculation Report (only available when the N1 is used with the independent external display)

◆ Renal Calculation Report (only available when the N1 is used with the independent external display)

ST Report (Realtime)

BeneVision N1 Patient Monitor Operator’s Manual 18 - 5

◆ QT Report (Realtime)

OxyCRG Report (only available when the N1 is used with the independent external display)

◆ PAWP Report (only available when the N1 is used with the independent external display)

History reports

◆ Tabular Trends Report

◆ Graphic Trends Report

◆ Event List Report

◆ Event Detail Report

◆ Full Disclosure Overview Report

◆ Full Disclosure Detail Report

◆ 12-Lead Review Interpretation Report (review)

◆ OxyCRG Report (review, only available when the N1 is used with the independent external display)

◆ OxyCRG review Report (review)

End Case Report

◆ End Case Report Realtime Report

◆ End Case Report ECG Report

◆ End Case Report Tabular Trends Report

◆ End Case Report Graphic Trends Report

18 - 6 BeneVision N1 Patient Monitor Operator’s Manual

19

Using the On-Screen Timers

The monitor has a Timer function to notify you when a preset time period is expired or how much time has elapsed. You can simultaneously display up to four timers.

19.1

Displaying Timers

To display a timer, follow this procedure:

1.

Access Tile Layout in either of the following ways:

◆ Select the Screen Setup quick key → select the Tile Layout tab.

◆ Select the Main Menu quick key → from the Display column select Tile Layout .

2.

Click the numeric tile area where the timer is to be displayed, and then select a timer from the popup list.

19.2

Controlling the Timer

The timer provides the following controls, depending on the state and settings of the timer:

Start

Reset

: starts the timer.

Pause : pauses the timer.

Resume : resumes the timer.

: clears the timer.

19.3

Setting the Timer

You can set each timer independently. To set the timer, follow this procedure:

1.

Select the timer area to enter the Timer Setup dialog.

2.

Set Timer Type :

Normal : The timer has a single and defined run time, and stops with a notification beep when the run time is reached.

◆ Advanced : The timer has a single and defined run time. When the run time is reached, the timer makes a notification beep and continuously displays the time beyond the end of run time.

Cycled : The timer has a single and defined run time. When the run time is reached, the timer makes a notification beep and restarts automatically. The number of elapsed cycles is also displayed on the left of the Timer tile.

Unlimited : The timer displays the time elapsed since the timer was started.

Clock : The timer displays the system time.

3.

Set Direction .

Up : the timer counts up, from zero to Run Time.

Down : the timer counts down, from Run Time to zero.

4.

Set Run Time .

5.

Set Reminder Volume .

A progress bar is shown with the run time. When the remaining time is 10 seconds, the monitor issues a reminder tone and the timer flashes in red, prompting you that the run time is about to expire.

NOTE

You cannot change timer settings, other than Reminder Volume when a timer is running.

You can set Direct, Run Time, and Reminder Volume only for normal, advanced, and cycled timers.

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20

Managing Configurations

20.1

Configuration Introduction

When performing continuous monitoring on a patient, the clinical professional often needs to adjust the monitor’s settings according to the patient’s condition. The collection of all these settings is called a configuration. The system configuration items can be classified as: parameter configuration items, conventional configuration items, and user maintenance items. Allowing you to configure the monitor more efficiently, the monitor provides different sets of configurations to accommodate the varying patient categories and departments. You can change some settings from a certain set of configuration and then save the changed configuration as a user configuration.

The default configurations provided for your monitor are department-oriented. You can choose either from:

General

OR

ICU

Neonatology

CCU

Each department has three different sets of configurations tailored for adult, pediatric and neonatal patients respectively.

WARNING

The configuration management function is password protected. The configuration management tasks must be performed by clinical professionals.

20.2

Changing the Department

If the current department configuration is not the one you want to view, you can change the department by following this procedure:

1.

Select the Main Menu quick key → from the Configuration column select Manage → input the required password

→ select .

2.

Select Change Department .

3.

Select a department.

4.

Select Ok .

CAUTION

Changing the department will delete all current user configurations.

20.3

Setting Default Patient Category

To set the default patient category when admitting a new patient, follow this procedure:

1.

Select the Main Menu quick key

from the Configuration column select Manage

→ input the required password → select .

2.

Set Default Patient Category .

20.4

Setting Default Configuration

The monitor will load the pre-set default configuration in the following cases:

BeneVision N1 Patient Monitor Operator’s Manual 20 - 1

A patient is admitted.

A patient is discharged.

Patient category is changed.

To set the default configuration, follow this procedure:

1.

Select the Main Menu quick key

from the Configuration column select Manage

→ input the required password → Select .

2.

Select Select Default Config .

3.

Select Load the Latest Config or Load Specified Config .

◆ When you select Load Specified Config , the restored configuration is subject to the patient category

(adult, pediatric or neonate). This configuration can be either factory configuration or a saved user configuration. As an example, select Default Adult Config and then select Factory Default or user configuration(s).

◆ When you select Load the Latest Config , the latest configuration is loaded when the monitor is started or a patient is admitted.

20.5

Saving Current Settings

Current settings can be saved as a user configuration. Up to 25 user configurations can be saved.

To save current settings, follow this procedure:

1.

Select the Main Menu quick key → from the Configuration column select Manage → input the required password

Select .

2.

Select Save Current Settings .

3.

Input the configuration name.

4.

Select Ok to save current settings as a user configuration.

20.6

Deleting a Configuration

To delete a configuration, follow this procedure:

1.

Select the Main Menu quick key → from the Configuration column select Manage → input the required password

Select .

2.

Select Delete Configuration .

3.

Select the configuration you want to delete:

◆ In the Delete Configuration dialog, selecting Local tab shows the existing user configurations on the monitor.

◆ In the Delete Configuration dialog, selecting USB Drive tab shows the existing user configurations on the USB drive.

4.

Select Delete .

5.

Select Ok .

20.7

Transferring a Configuration

When installing several monitors with identical user configurations, it is not necessary to set each unit separately. Use a USB drive to transfer the configuration from monitor to monitor.

20.7.1

Exporting a Configuration

To export the current monitor’s configuration, follow this procedure:

1.

Connect the N1 to the Dock.

2.

Connect the USB drive to the Dock’s USB port.

3.

Select the Main Menu quick key

from the Configuration column select Manage

→ input the required password → Select .

20 - 2 BeneVision N1 Patient Monitor Operator’s Manual

4.

Select Export Configuration .

5.

Select the configurations and User Maintenance Settings to export.

6.

Select Export .

20.7.2

Importing a Configuration

To import the configuration from the USB drive to the monitor, follow this procedure:

1.

Connect the N1 to the Dock.

2.

Connect the USB drive to the Dock’s USB port.

3.

Select the Main Menu quick key

from the Configuration column select Manage

→ input the required password → Select .

4.

Select Import Configuration .

5.

Select the configurations and User Maintenance Settings to import.

6.

Select Import .

20.7.3

Loading a Configuration

You may make changes to some settings during operation. However, these changes or the pre-selected configuration may not be appropriate for the newly admitted patient. Therefore, the monitor allows you to load a desired configuration to ensure that all the settings are appropriate for your patient.

To load a configuration, follow this procedure:

1.

Select the Main Menu quick key → from the Configuration column select Load .

2.

Select the desired configuration.

◆ Select the configuration on this monitor in the Local page.

◆ Select the configuration on the USB drive in the USB Drive page.

3.

Select Load .

NOTE

The monitor may configure some settings by default when you load a configuration of different software version with the current configuration.

20.8

Printing Configurations

To print both factory configurations and user configurations, follow this procedure:

1.

Select the Main Menu quick key

→ from the Configuration column select Manage

→ input the required password → select .

2.

Select Print Configuration .

3.

Select desired configurations.

4.

Select Print .

20.9

Modifying Configuration Password

To modify the configuration password, follow this procedure:

1.

Select the Main Menu quick key

from the Configuration column select Manage

→ input the required password → Select .

2.

Select Modify Password .

3.

Respectively input the old password and new password.

4.

Select OK .

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20 - 4 BeneVision N1 Patient Monitor Operator’s Manual

21

Password-protected User Settings

This chapter describes the password-protected functions accessed in the Maintenance dialog.

21.1

Setting the Device Location

21.1.1

Setting Monitor Information

To set monitor information, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Device Location tab.

3.

Input monitor name, facility name and department name.

21.1.2

Setting Monitor Location

If your monitor is installed at a fixed position, or you do not need clinicians to change the room number and bed number, you can set Monitor Location to Fixed . To set the monitor location, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Device Location tab.

3.

Set Location .

◆ Fixed : the Patient Management dialog displays Bed No.

and Room No.

, but you cannot change them.

Unfixed : you can change Bed No.

and Room No.

from the Patient Management dialog.

4.

Input the room number and bed number.

NOTE

If Location is set to Unfixed, Bed No.

and Room No.

are cleared from the Device Location tab each time you discharge a patient.

21.1.3

Enabling the Auto Obtain Bed Number Function

If the monitor is connected to the wired network, the monitor can automatically set the patient’s bed number according to the bed number information bonded to the bedside network connector.

To enable this function, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Device Location tab.

3.

Select Unfixed .

4.

Switch on Auto Obtain Bed No..

NOTE

The Auto Obtain Bed Number function is available only when the switch connected to the monitor supports the LLDP or CDP protocol, and the corresponding protocol is enabled.

BeneVision N1 Patient Monitor Operator’s Manual 21 - 1

21.2

Changing Patient Management Settings

21.2.1

Selecting Displayed Patient Information

You can define which items can be displayed and edited from the Patient Management tab. To do so, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Patient Management tab.

3.

Select the fields you want to display in the Patient Management dialog.

4.

If necessary, select the customized fields and input names for these fields.

NOTE

If the monitor is connected with the CMS, the patient information items and customized fields are loaded from the CMS.

21.2.2

Auto Discharging a Patient after Monitor Power Off

You can let the monitor automatically discharge after the monitor has been switched off for a period of time.

To set the time period of discharging a patient, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Patient Management tab

→ select the Discharge tab.

3.

Select a time for Auto Discharge When Power Off . The monitor will automatically discharge the patient when it is turned off for the designated period of time. The default is Never . That is to say the monitor will not automatically discharge a patient, regardless of how long the monitor has been switched off.

21.2.3

Clearing All Patient Data

You can delete all patient information and data in the monitor. To do so, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password

select .

2.

Select the Patient Management tab

→ select the Discharge tab.

3.

Select Clear All Patient Data .

4.

Select OK . Select OK again for confirmation until a message indicating you that all data is cleared.

CAUTION

Clearing patient data will discharge the current patient. Make sure there is no patient is being monitored before you clear all data.

21.2.4

Selecting Query Criteria for Searching Patients in ADT Server

You can define which criteria can be used to search patients in the ADT server. To do so, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Patient Management tab → ADT Query tab.

3.

Select the query criteria as desired.

21.2.5

Setting Patient Location Options for the Discharge Screen

To set options for patient location, follow this procedure:

21 - 2 BeneVision N1 Patient Monitor Operator’s Manual

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

select .

2.

Select the Patient Management tab

select the Location tab.

3.

Input or edit patient location options.

21.2.6

Hiding Patient Name

To hide patient name on specific screens, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

select .

2.

Select the Patient Management tab

select the Display tab.

3.

Set the following switches as desired:

◆ Switch off Primary Screen Display Full Name : does not display patient name in the patient information area on the primary display.

◆ Switch off Secondary Screen Display Full Name : does not display patient name in the patient information area on the secondary display, if configured.

◆ Switch off Remote View Display Full Name : does not display patient name in the patient information area on the remote monitors when this monitor is viewed by other monitors.

◆ Switch off Remote View Bedlist Display Full Name : does not display patient name in bed list on the remote monitors when this monitor is viewed by other monitors.

21.2.7

Select Whether a Prompt is Required When Auto Deleting Discharged Patients

The monitor automatically delete earlier discharged patients when the memory is limited. You can select whether an alarm is issued when discharged patients are automatically deleted and the monitor memory is very low.

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Set the Review tab → Discharged Patients tab.

3.

Configure the alarms as needed:

◆ Prompt on patient auto deleted: an alarm is issued when the monitor automatically deletes earlier discharged patients.

◆ Alarm on storage is nearly full : selects whether an alarm is issued when the monitor memory is very low and the priority of this alarm.

21.3

Changing the Alarm Settings

21.3.1

Setting Alarm Tone Properties

21.3.1.1

Setting the Minimum Alarm Volume

To set the minimum alarm volume, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Alarm tab

Audio tab.

3.

Set Minimum Alarm Volume .

21.3.1.2

Setting the Audible Alarm Tone Pattern

You can distinguishes the heart beat tone, pulse tone, and keystroke tone by frequency. You can choose any of the three tone patterns: ISO, Mode 1, and Mode 2. For more information, see

6.3.3 Alarm Indicators .

To set the alarm tone pattern, follow this procedure:

BeneVision N1 Patient Monitor Operator’s Manual 21 - 3

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password → select .

2.

Select the Alarm tab

Audio tab.

3.

Set Alarm Sound to ISO , Mode 1 or Mode 2 .

21.3.1.3

Setting the Interval between Alarm Sounds

If you choose the ISO pattern, you can change the interval between alarm tones. To change the interval between alarm tones, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password → select .

2.

Select the Alarm tab

Audio tab.

3.

Set High Alarm Interval , Med Alarm Interval , and Low Alarm Interval .

21.3.1.4

Setting Alarm Volume Escalation

The monitor provides the function of automatically escalating the alarm tone volume. When this function is enabled, if an alarm is not reset within the designated delay time after the alarm occurs, the volume of the alarm tone increases automatically.

To set the alarm volume escalation, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password → select .

2.

Select the Alarm tab

Audio tab.

3.

Set Auto Increase Volume .

2 Steps : if an alarm is not reset within the designated delay time after the alarm occurs, the alarm volume automatically increases by two levels.

◆ 1 Step : if an alarm is not reset within the designated delay time after the alarm occurs, the alarm volume automatically increases by one level.

Off : if an alarm is not reset within the designated delay time after the alarm occurs, the volume of the alarm tone does not change.

4.

Select Increase Volume Delay to set the delay time of alarm volume escalation.

NOTE

The alarm volume escalation function is not applied to the latched alarms.

21.3.2

Setting Alarm Pausing and Resetting Properties

21.3.3

Defining the Pause Function

You can either pause alarms or pause alarm tones. This depends on the pause setting. To set the pause function, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

select .

2.

Select the Alarm tab → Pause/Reset tab.

3.

Set Pause to Alarm Pause or Audio Pause .

21.3.3.1

Setting the Alarm Pause Time/Alarm Tone Pause Time

The alarm pause time or alarm tone pause time can be set to 1 min , 2 min , 3 min , or Permanent . The default audio pause time is two minutes.

To set the alarm tone pause time, follow this procedure:

21 - 4 BeneVision N1 Patient Monitor Operator’s Manual

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password → select .

2.

Select the Alarm tab

Pause/Reset tab.

3.

Set Pause Time .

21.3.3.2

Setting the Priority of Audio Paused Alarms

To select alarm of what priority can be paused or alarm sound of what priority can be paused, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password → select .

2.

Select the Alarm tab

Pause/Reset tab.

3.

Set Pause Priority .

All : pressing the Alarm Pause quick key pauses all alarms.

Med & Low : pressing the Alarm Pause quick key pauses alarms of medium and low priority. The high priority alarms will not be paused.

◆ Disable : the Alarm Pause quick key is disabled.

21.3.3.3

Disabling the Options of Prolonging Alarm Pause Time/Alarm Tone Pause Time

To disable specific options for the clinician when prolonging alarm pause time or the alarm tone pause time, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Alarm tab

Pause/Reset tab.

3.

Switch off Pause 5 min , Pause 10 min , or Pause 15 min .

21.3.3.4

Setting Alarm Light Status on Alarm Reset

When the alarm system is reset, the monitor presents the alarm light by default , but you can switch off the alarm light. To change the alarm light setting, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Alarm tab

Pause/Reset tab.

3.

Set Alarm Light .

On When Reset : when the alarm system is reset, the alarm tones of the current alarms are switched off, but the alarm lamp remains flashing.

◆ Off When Reset : when the alarm system is reset, both the alarm tone and alarm lamp of the current alarms are switched off.

21.3.3.5

Setting the Reminder Tones

When the alarm volume is set to zero, or the alarm is reset or switched off, the monitor issues a periodical reminder tone. The reminder tone is enabled by default.

To set the reminder tone, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Alarm tab → Pause/Reset tab.

3.

Set Alarm Reset Reminder and Alarm Off Reminder .

On : the monitor issues reminder tones at a designated interval.

BeneVision N1 Patient Monitor Operator’s Manual 21 - 5

◆ Re-alarm : if the alarm condition persists the alarms marked with “√” will be re-generated after the designated reminder tone interval.

Off : the monitor does not issue reminder tones at a designated interval. The alarms marked with “√” will be silenced.

4.

Set Reminder Interval to 10 min , 5 min , 3 min , 2 min , or 1 min .

21.3.4

Latching Physiological Alarms

To latch physiological alarms, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password → select .

2.

Select the Alarm tab

Latching tab.

3.

Select how you want to latch the alarms.

Alarm latching rules are as follows:

You can separately latch visible alarm signals and audible alarm signals.

Latching audible alarm signals simultaneously latches the corresponding visible signals.

Selecting alarms of lower priority simultaneously latches higher priority alarms.

Switching V-Tach Latching Lock off allows you to switch on or off V-Tach Latching .

When V-Tach Latching Lock is switched on, V-Tach latching follows the setting of Lethal alarm latching and you cannot control V-Tach Latching .

21.3.5

Changing Remote Alarm Settings

21.3.5.1

Resetting Alarms for Remote Devices

You can reset the alarms occurring on the remote devices that are viewed on the Remote View screen of the monitor. To enable this function, follow this procedure:

1.

Select the Main Menu quick key

→ from the System column select Maintenance

→ input the required password → select .

2.

Select the Alarm tab → Remote View tab.

3.

Switch on Reset Remote Bed Alarms . Then the Alarm Reset button appears on the bottom left of the

Remote View screen.

To reset any remote device alarms, the clinician may now select the Alarm Reset button at the bottom of the

Remote View screen.

NOTE

You can reset remote device alarms only if the Alarm Reset By Other Bed switch is on at the remote devices and alarms are occurring on the remote device.

21.3.5.2

Authorizing the Alarm Reset to Other Devices

Alarms on your monitor can be reset by remote devices if you enable this function. To do so, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Alarm tab

Remote View tab.

3.

Switch on Alarm Reset By Other Bed .

21.3.5.3

Selecting the Alarm Reminder for Remote Devices

You can configure what alarm indicators are necessary for the remote devices. To do so, follow this procedure:

21 - 6 BeneVision N1 Patient Monitor Operator’s Manual

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Alarm tab

Remote View tab.

3.

Select Alarm Reminder :

◆ Visible + Audible : the monitor provides visual alarm indication, and continuous audible alarm indication if the alarm persists at the remote device.

Visible + Single Tone : the monitor provides visual alarm indication, and a single tone when the alarm occurs at the remote device.

◆ Visible Only : the monitor only provides visual alarm indication.

21.3.5.4

Presenting Alarm Sound for Remote Devices as per Alarm Priority

You can configure what priority of remote device alarms are presented for audible notification. To do so, follow this procedure:

1.

Select the Main Menu quick key

→ from the System column select Maintenance

→ input the required password → select .

2.

Select the Alarm tab → Remote View tab.

3.

Select Alarm Priority :

All : the monitor sounds if an alarm occurs.

High & Med : the monitor sounds if a high or medium priority alarm occurs.

High Only : the monitor sounds only if a high priority alarm occurs.

21.3.5.5

Setting the Tone Pattern for Alarms from Remote Devices

The monitor provides the same alarm tone pattern for the remote device alarms as those for your monitor alarms. For more information on alarm tone pattern, see

6.3.3 Alarm Indicators .

To set the alarm tone pattern for the remote device alarms, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Alarm tab

→ select the Remote View tab.

3.

Set Alarm Sound to ISO , Mode 1 or Mode 2 .

21.3.5.6

Switching Off the Remote Device Disconnection Alarm

The monitor can provide an alarm if remote devices, for example, a bedside monitor or a telemetry, are disconnected. By default, the function is enabled. To disable the alarm, follow this procedure:

1.

Select the Main Menu quick key

→ from the System column select Maintenance

→ input the required password → select .

2.

Select the Alarm tab → Remote View tab.

Switch off Remote Disconnected Alarm .

21.3.6

Changing Alarm Priority Settings

21.3.6.1

Setting the Priority of the ECG Lead Off Alarm

To set the priority of the ECG lead off alarm, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Alarm tab

select the Other tab.

3.

Set the priority of ECG Lead Off .

BeneVision N1 Patient Monitor Operator’s Manual 21 - 7

21.3.6.2

Setting the Priority of the SpO

2

Sensor Off Alarm

To set the priority of the SpO

2

sensor off alarm, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Alarm tab

select the Other tab.

3.

Set the priority of SpO2 Sensor Off .

21.3.6.3

Setting the Priority of the IBP No Sensor Alarm

To set the priority of the IBP no sensor alarm, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Alarm tab

select the Other tab.

3.

Set the priority of IBP No Sensor .

21.3.6.4

Setting the Switch of the CMS and eGateway Disconnection Alarm

You can choose whether to issue an alarm when the monitor is not connected or disconnected from the CMS/ eGateway. To do so, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

select .

2.

Select the Alarm tab → Other tab.

3.

In the Other block, switch on or off CMS/eGW Disconnected Alarm . If CMS/eGW Disconnected Alarm is switched off, the “Offline” alarm is not presented when the monitor is not connected or disconnected from the CMS/eGateway.

21.3.6.5

Setting the Priority of the CMS and eGateway Disconnection Alarm

To set the priority of the CMS and eGateway disconnection alarm, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Alarm tab

Other tab.

3.

Set CMS/eGW Disconnected .

21.3.6.6

Setting the Switch of the SpO

2

Desat Alarm Off

You can choose whether switching off the SpO

2

Desat alarm is permissible or not. To do so, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password → select .

2.

Select the Alarm tab

→ select the Other tab.

3.

Set SpO2 Desat Alarm Off .

Disable : the SpO

2

Desat alarm is always on. You cannot switch it off.

Enable : you can switch off the SpO

2

Desat alarm. For more information, see 10.6.1 Changing the SpO

2

Alarm Settings

.

WARNING

If a clinician switches off the SpO2 Desat alarm, the monitor will not alarm when the patient’s SpO

2

is extremely low. This may result in a hazard to the patient.

21 - 8 BeneVision N1 Patient Monitor Operator’s Manual

21.3.6.7

Setting the Switch of the Zero RR Alarm Off

You can choose whether switching off the zero RR alarm is permissible or not. To do so, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Alarm tab

→ select the Other tab.

3.

Set Zero RR Alarm Off .

Disable : the zero RR alarm is always on. The clinician cannot switch it off.

Enable : the clinician can switch off the zero RR alarm. For more information, see

11.5.1 Setting the Resp

Alarm Properties .

WARNING

If a clinician switches off the zero respiration rate alarm, the monitor will not issue the zero respiration rate alarm when that situation occurs. This may result in a hazard to the patient. Keep the patient under close surveillance.

21.3.7

Changing Alarm Delay Settings

21.3.7.1

Setting the Alarm Delay Time

For continuously measured parameters, you can set the alarm delay time. If the alarm condition is resolved within the delay time, the monitor does not present the alarm.

To set the alarm delay time, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Alarm tab → Other tab.

3.

Set Alarm Delay .

◆ Off : an alarm is presented as soon as the alarm condition occurs.

◆ 1 sec ~ 8sec : for continuously measured parameters, an alarm is not presented if the alarm condition is resolved within the designated delay time.

The setting of Alarm Delay is not applied to the zero respiration rate alarms and the ST alarms. You can set Zero

RR Delay and ST Alarm Delay separately.

WARNING

The alarm delay time can be set to a maximum of 8 seconds. Changing this setting to an inappropriate level could result in a hazard to the patient.

21.3.7.2

Setting the ST Alarm Delay Time

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Alarm tab

Other tab.

3.

Set ST Alarm Delay .

21.3.8

Adjusting the Alarm Light Brightness

To adjust the alarm light brightness, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password → select .

BeneVision N1 Patient Monitor Operator’s Manual 21 - 9

2.

Select the Alarm tab → Other tab.

3.

From the Alarm Light Brightness area, set Primary Screen (note that you may have to scroll up the dialog to see this option). If you set alarm light brightness to Auto , the monitor automatically adjusts the alarm light brightness according to the ambient light. The stronger the ambient light is, the brighter the alarm light is.

21.3.9

Changing Other Alarm Settings

21.3.9.1

Setting the Lethal Arrhythmia Alarms Switch

To allow a clinician to disable the lethal arrhythmia alarms, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Alarm tab

select the Other tab.

3.

From the Other block, set Lethal Arrh Alarms Off as follows.

Lethal Arrh Alarms Off is set to Disable by default. In this case, a clinician cannot switch off lethal arrhythmia alarms.

◆ If you set Lethal Arrh Alarms Off to enable , a clinician can switch off lethal arrhythmia alarms from the ECG

dialog. For more information, see 7.6.4.1 Changing Arrhythmia Alarm Settings .

WARNING

If any of lethal arrhythmia alarms are switched off, the ECG waveform area displays a message to indicate that corresponding alarms are off.

If a clinician switches off all arrhythmia alarms, the monitor will not present arrhythmia alarms.

Always keep the patient under close surveillance.

21.3.9.2

Setting the Intubation Time

The default intubation time is 2 minutes. To change the intubation time, following this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password → select .

2.

Select the Alarm tab

Other tab.

3.

Set the Intubation Mode Period .

21.3.9.3

Setting Arrhythmia Alarm Timeout Period

The arrhythmia algorithm can disable alarm light and alarm tone for designated period of time when certain arrhythmia alarms are detected.

To set the arrhythmia alarm timeout period, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Alarm tab → select the Other tab.

3.

From the Other block, set Arrhy Shield Time .

NOTE

For the following alarms, alarm light and alarm tone cannot be disabled: HR high, HR low,

Tachycardia, Bradycardia, Afib End, Irr Rhythm End.

The arrhythmia alarm timeout period is only applied to the medium priority chains and atrial fibrillation chain. For the alarms in the high priority chain, alarm tone and alarm light are presented as soon as the alarm condition is detected. Refer to

7.6.5.1 Arrhythmia Alarm Chains for more

information on the arrhythmia alarm chain.

21 - 10 BeneVision N1 Patient Monitor Operator’s Manual

Alarm indication rules for alarms in the atrial fibrillation chain are the same with those for the medium priority chains.

21.4

Changing CAA Settings (only available when the N1 is used with the independent external display)

21.4.1

Enabling Inputing the Clinician ID

To display the clinician ID on the EWS screen, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the CAA tab → select the EWS tab.

3.

Switch on Clinician ID .

4.

Select Clinician ID Timeout to set how long the clinician ID will remain valid.

NOTE

The EWS tab is only available if a license for EWS is installed in the monitor.

When a patient is discharged, or the monitor is turned off, the clinical ID is cleared even if the timeout is not reached.

21.4.2

Selecting the Default Scoring Tool

To set the default scoring tool for different patient category, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the CAA tab → select EWS tab.

3.

From the Select Default Score area, set Default Adult Score , Default Ped Score , and Default Neo Score .

21.4.3

Managing the Scoring Tools

To manage the scoring tool, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the CAA tab

→ select EWS tab.

3.

Select the Manage Score button.

◆ Delete local scoring tools: from the Local page, delete any unnecessary scoring tools.

◆ Import the desired scoring tools to the monitor: from the USB drive page, select the scoring tools on the USB drive, and then select Import .

NOTE

The monitor provides MEWS and NEWS by default. You cannot delete them.

21.4.4

Setting GCS Threshold for Each Consciousness Level

You can configure the threshold and color of each consciousness level. To do so, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the CAA tab → select the GCS tab.

3.

Set high limit, low limit for each level.

BeneVision N1 Patient Monitor Operator’s Manual 21 - 11

21.5

Changing Module Settings

21.5.1

Selecting the ECG Standard

Select the ECG standard according to the leadwires you are using. To select the ECG standard, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Module tab → ECG tab.

3.

Set ECG Standard to AHA or IEC .

21.5.2

Changing the QTc Formula

The monitor uses the Hodges correction formula by default to correct the QT interval for heart rate. To select the

QTc formula, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

select .

2.

Select the Module tab

ECG tab.

3.

Set QTc Formula .

◆ Hodges:

QTc = QT + 1.75

× ( HeartRate – 60 )

◆ Bazett:

QTc = QT ×

HeartRate

60

2

◆ Fridericia:

QTc = QT ×

HeartRate 

3

◆ Framingham:

QTc = QT + 154 ×

1 –

60

HeartRate

21.5.3

Setting the 12-Lead Order Switch

To set whether to send the order number of 12-lead interpretation report to the hospital information system while saving the report, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → i nput the required password

→ select .

2.

Select the Module tab.

3.

Select the ECG tab.

4.

Set 12-Lead Order .

21.5.4

Calibrating ECG

The ECG signal may be inaccurate due to hardware or software problems. As a result, the ECG waveform amplitude becomes greater or smaller. In that case, you need to calibrate the ECG module. To do so, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

select .

2.

Select the Module tab

ECG tab.

3.

From the bottom left corner of the dialog select Calibrate .

21.5.5

Manually Zeroing the CO

2

Module

To zero the CO

2

module, follow this procedure:

21 - 12 BeneVision N1 Patient Monitor Operator’s Manual

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Module tab

CO2 tab.

3.

From the bottom left corner of the dialog select Zero .

21.5.6

Hiding the Invalid Display after Zeroing the CO

2

Module

After the zero calibration is completed, the CO

2

module reacquires the CO

2

readings. During the reacquisition period, “ Zero Recovering ” is displayed in the CO

2

numeric area. Valid data will reappear 30 seconds after the zero calibration is started.

To hide the display of the “ Zero Recovering ” message, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Module tab

CO2 tab.

3.

Switch off Zero Recovery for 30s .

Selecting Defaults from the bottom of the dialog can restore this setting to the factory default.

21.5.7

Setting Parameter Measurement Timeout

NIBP measurements become outline fonts after a preset time. This feature prevents older values being misinterpreted as current measurements. To adjust the timeout period for PAWP, C.O., and NIBP, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password → select .

2.

Select the Module tab → select the Other tab.

3.

Set the timeout period for PAWP and NIBP.

21.5.8

Setting Flow Rate (For Sidestream CO

2

Module Without O

2

)

When you are using the sidestream CO

2

module without the O

2

monitoring function to monitor a neonatal patient, you can select flow rate. To do so, follow this procedure:

1.

Ensure that the sidestream module without O

2

is inserted in the monitor.

2.

Select the Main Menu quick key

from the System column select Maintenance

input the required password

→ select .

3.

Select the Module tab → Other tab.

4.

Set CO2 Flow Rate For Neo .

21.6

Hiding Undesired Review Tabs

If you do not need to review some items, you can hide them. To do so, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Review tab.

3.

From the Tabs page, Event page or Arrh Mark page deselect those that do not need to be available to clinicians during review.

21.7

Setting the Printer

21.7.1

Setting the Printer Properties

To set a network printer, follow this procedure:

BeneVision N1 Patient Monitor Operator’s Manual 21 - 13

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Print tab.

3.

In the Printer tab, select Connection Type to choose whether you want to output patient reports via the print server or a network printer.

4.

If you set Connection Type to Print Server , perform the following settings:

◆ Print Server Address : select

◆ Port : selects to input the print server name or IP address.

to input the print server port. If the CMS is used as the print server, set Port to 6603 .

◆ Set the report type in the Report Type area. For more information, see section

21.7.2 Setting the

Report Type .

5.

If you set Connection Type to Printer , perform the following settings:

◆ Select Printer IP Address . Select

◆ Select Paper Size .

◆ Select Resolution .

to input the IP address of the desired network printer.

After finishing configurations, you can select the Print Test Page button to verify that the printer works properly.

21.7.2

Setting the Report Type

If the Connection Type is set to Print Server , you need to set the report type:

1.

Select the Main Menu quick key

→ from the System column select Maintenance

→ i nput the required password → select .

2.

Select the Print tab.

3.

Set Connection Type to Print Server .

4.

Select the report you intend to set, for example, General Report .

5.

Set the Print Action :

◆ Paper : outputs paper report.

◆ PDF : outputs the electronic report in PDF format.

◆ Paper And PDF : outputs both the paper report and the PDF report.

6.

For paper report, respectively select Printer and Printer Resolution to set the default printer and the resolution for the default printer.

7.

For PDF report, select the PDF Resolution to set the resolution.

NOTE

General reports refer to the reports other than the end case report and realtime alarm report.

21.7.3

Setting the Report Layout

To set the patient information you want to display on general reports, follow this procedure:

1.

Select the Main Menu quick key

→ from the System column select Maintenance

→ input the required password → select .

2.

Select the Print tab.

3.

Select the Report Layout tab.

4.

Select the desired items under Report Name . N/A indicates that this item is not displayed on a report.

21.7.4

Setting Patient Information on 12-lead ECG Reports

To set the patient information you want to display on 12-lead ECG reports, follow this procedure:

1.

Select the Main Menu quick key

→ from the System column select Maintenance

→ input the required password → select .

21 - 14 BeneVision N1 Patient Monitor Operator’s Manual

2.

Select the Print tab.

3.

s elect the ECG Report tab.

4.

On the right of the ECG Report page, select the desired patient information items. Patient ID, Patient

Name, Age, and Gender are displayed on an ECG report by default.

NOTE

You can only set the patient information to display on the ECG report from the ECG Report page.

Patient information configured in the Report Layout page is not applied to ECG reports.

21.7.5

Configuring the Name of PDF Files

If you use the print server to output patient reports, you can use the PDF printer to output PDF format reports. To configure the name of PDF files, follow this procedure:

1.

Select the Main Menu quick key

→ from the System column select Maintenance

→ input the required password

→ select .

2.

Select the Print tab → PDF File Name tab.

3.

Select the desired items and their sequence under PDF File Name . N/A refers to no information.

21.7.6

Showing the Second Mark

To set whether you want to show second marks on the report output by the printer, follow this procedure.

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password

→ select .

2.

Select the Print tab

Other tab.

3.

Enable or disable Second Mark (Printer) .

21.7.7

Setting Parameter Unit

To set parameter unit, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password

→ select .

2.

Set the Unit tab.

3.

Set unit for each parameter.

21.8

Setting the Time

21.8.1

Setting the Time Synchronization

The monitor can automatically synchronize its time with a time server on which NTP (Network Time Protocol) is implemented. If there are many monitors connected within one network, you can enable the time synchronization to synchronize the time, and make it unnecessary to manually set the time for individual monitors.

21.8.1.1

Setting the Time Server Address

To set the DNS name of the time server address, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Time tab

Time Synchronization tab.

3.

Input the name or IP address of the time server.

After configuring the NTP time server, select Network Test to verify that the NTP server is properly connected.

BeneVision N1 Patient Monitor Operator’s Manual 21 - 15

21.8.1.2

Setting the Time Synchronization Interval

To set the time synchronization interval, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Time tab

Time Synchronization tab.

3.

Set Interval .

21.8.1.3

Disabling the Time Synchronization Function

To disable the time synchronization function, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Time tab

Time Synchronization tab.

3.

Switch off Start NTP Time Sync .

21.8.2

Enabling Auto Daylight Savings Time

By default, daylight savings time is disabled. If this function is needed, you need to manually enable the daylight savings time. To auto start the daylight savings time, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Time tab

Daylight Savings Time tab..

3.

Switch on Auto Daylight Savings Time .

4.

Adjust daylight savings time settings as necessary.

NOTE

If you enable Auto Daylight Savings Time you cannot manually switch it on or off from the System

Time dialog. For more information, see 3.8.1 Setting the Date and Time.

21.9

Viewing Version Information

To view the system software version, module hardware and software version, and firmware version , follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Version tab.

You can also view the system software version by selecting the Main Menu quick key → from the System column select Version .

21.10

Checking Battery Information

To check the battery information, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Battery Information tab.

21.11

Changing Scanner Settings

For the 2D barcode reader, you can change the scanner settings.

21 - 16 BeneVision N1 Patient Monitor Operator’s Manual

21.11.1

Establish the Relationship between Patient Demographics and 2D Barcode

Fields (for the Mindray Custom 2D Barcode Reader)

To configure 2D barcode reader, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Scanner tab → 2D Barcode tab.

3.

Establish the relationship between the monitor data and hospital’s barcode data for selectable patient demographics. For example, the monitor has an option of Ped for patient category. In your hospital barcode, the text may read as Pediatric . So input Pediatric for the field Ped to establish their relationship.

21.11.2

Setting the Barcode Reader Information

To set the barcode reader information, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

select .

2.

Select the Scanner tab

Scanner Info.

tab.

3.

Set Scanner Type :

◆ 1D Scanner : select this option when using a 1D scanner or a 2D scanner other than the Mindray custom 2D scanner.

◆ 2D Scanner : select this option when using the Mindray custom scanner.

NOTE

When you set Scanner Type to 2D Scanner, default settings are applied to Data Encoding Type and

Data Parse Mode. You do not need to change these setting.

21.11.3

Identifying the Barcode Reader (for the non-Mindray Custom 2D Barcode

Reader)

When you are using barcode readers other than the JADAK Flexpoint HS-1R or HS-1M, you should select the barcode reader from the USB device list, so that the monitor can identify the barcode reader. To do so, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Scanner tab → Identify Scanner tab.

3.

From the USB device list, select the barcode reader you are using.

21.11.4

Selecting Patient Information Read by the Barcode Reader (for the Mindray

Custom 2D Barcode Reader)

To select desired patient information that will be read by the barcode reader, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

select .

2.

Select the Scanner tab

Field tab.

3.

Select the patient information. The selected information can be read by the barcode reader.

NOTE

The patient information read by the barcode reader is dependent on the patient information encoded in the hospital's barcodes.

BeneVision N1 Patient Monitor Operator’s Manual 21 - 17

21.12

Configuring the Network

You can connect the monitor to the central monitoring system (CMS), eGateway, and other monitors through wired LAN or wireless LAN.

21.12.1

Network Safety Information

CAUTION

Wireless network designing, deploying, debugging, and maintenance should be executed by

Mindray service personnel or authorized technicians.

Always set the wireless network according to local wireless regulations.

Keep network authentication information, for example passwords, safe, to protect the network from being accessed by unauthorized users.

Do not connect non-medical devices to the monitor network.

If wireless network signal is poor, there may be a risk of CMS-destined data loss.

RF interference may result in wireless network disconnection.

Disconnecting from the network may result in CMS-destined data loss and function failure. Check the patient in case of network disconnection and solve the network problem as soon as possible.

Ensure that the monitor IP address setting is correct. Changing the network settings may result in network disconnection. Contact your service personnel if there are any problems with the IP address.

21.12.2

Setting the Wireless Network

To add and set the wireless network, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Network Setup tab → WLAN tab.

3.

Select Add WLAN . In the popup dialog, input network name, SSID, and password. Set Security .

4.

Select the WLAN IP tab and select how to get the IP address and DNS address.

◆ Obtain IP Address Automatically : the monitor automatically gets the IP address.

◆ Use the Following Address : you need to input the IP address , Subnet Mask , and Gateway .

◆ Obtain DNS Address Automatically : the monitor automatically gets the DNS address.

◆ Use the following DNS Address : you need to input the IP address of Preferred DNS server and

Alternate DNS server .

5.

Select the WLAN Setup tab and set WLAN band and channels. The default is Auto , which means the monitor can automatically identify the WLAN band.

After configuring the wireless network, select Network Test to verify that the wireless network can be properly connected.

If you need to change network settings, select beside the desired wireless network. Selecting deletes the wireless network.

21.12.3

Managing Certifications

You can delete certifications from the monitor, or import certifications from the USB memory device. To do so, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Network Setup tab → WLAN tab.

3.

Select the Certificate Management button from the bottom left corner of the dialog.

From the Local tab, select certifications you want to delete from the monitor, and then select Delete .

21 - 18 BeneVision N1 Patient Monitor Operator’s Manual

◆ From the USB Drive tab, select certifications you want to import from the USB memory device, and then select Import .

21.12.4

Enabling Selecting a CMS

To enable selecting a CMS, follow this procedure:

1.

Select the Main Menu quick key

→ from the System column select Maintenance

input the required password → select .

2.

Select the Network Setup tab → Central Station Setup tab.

3.

Switch on Select CMS .

21.12.5

Adding CMSs

You can add up to 30 central monitoring systems (CMS) for your monitor. To add CMSs, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

select .

2.

Select the Network Setup tab

Central Station Setup tab.

3.

Select Add Central Station , and then input the CMS name and IP address of this department.

21.12.6

Setting Multicast Parameters

Multicast helps device discovery between monitors and other devices on the network. Devices in the same multicast group can be mutually discovered.

To set multicast parameters, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Network Setup tab → Device Discover tab.

3.

Set Multicast TTL .

4.

Set Multicast Address .

21.12.7

Setting the Master Server Address

To set the DNS name of the master server, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Network Setup tab

Device Discover tab.

3.

Select Master Server Address to input the DNS name or IP address of the master server.

21.12.8

Setting the Network Service Quality Level

To set the quality of service (QoS), follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Network Setup tab → QoS tab.

3.

Select QoS Level For Realtime Monitoring to set the service quality of network connection for realtime monitoring, for example parameter measurements and waveforms, alarms, etc.

4.

Select QoS Level For Others to set the service quality of network connection for non-realtime monitoring, for example history data, printing, etc.

21.12.9

Using the ADT Gateway

The ADT (admit-discharge-transfer) gateway is normally deployed in the eGateway. You can obtain patient information from the hospital ADT server through the ADT gateway.

To configure the ADT gateway, follow this procedure:

BeneVision N1 Patient Monitor Operator’s Manual 21 - 19

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Network Setup tab

ADT tab.

3.

Select Server Address to input the host name or IP address of the ADT gateway.

4.

Select Port to input the port of the ADT gateway.

ADT Query is switched off by default. You can load patient information to the monitor from the ADT server only when this function is enabled.

After configuring the ADT gateway, select Network Test to verify that the ADT server is properly connected.

21.12.10 Sending Realtime Data, Waveforms and Alarms via HL7 Protocol

You can send the realtime data, waveforms, and alarms from the monitor to the hospital servers via HL7 protocol. To do so, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Network Setup tab

HL7 Configuration tab.

3.

From the Data + Waveforms area, select Server Address to input the name or IP address for the server receiving the realtime data and waveform. Set Port .

4.

Switch on Send Data and Send Waveform , as needed. Set Data Interval .

5.

From the Alarms area, select Server Address to input the name or IP address for the server receiving the alarm data. Set Port .

6.

Switch on Send Alarms as needed.

This page also displays the server connection status.

21.12.11 Selecting Data Encryption Type

To set data encryption type, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Network Setup tab

Information Security tab.

3.

Select Encryption Connection Type to set data encryption type when connecting devices:

◆ Only Private Encryption : Mindray private encryption is used to encrypt the transmitted data. You cannot connect devices supporting SSL (secure sockets layer) encryption.

◆ SSL Encryption Priority : for devices supporting SSL encryption, SSL encryption is used when connecting the devices. For devices not supporting SSL encryption, private encryption is used when connecting the devices.

21.12.12 Disabling the Broadcasting Patient Demographics Function

When viewing other patients, device location and patient information of remote devices are displayed in the remote device list by default. To protect patient privacy, you can disable the broadcasting of patient demographics function to prevent the monitor from sending patient information via broadcast. To do so, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

select .

2.

Select Network Setup tab

Information Security tab.

3.

Switch off Broadcast Patient Demographics .

Thus, patient information will not display in the remote device list.

21.13

MLDAP

MLDAP refers to Mindray LDAP (Lightweight Directory Access Protocol). It is an independent process which can be installed on the eGateway or other application server (Windows). MLDAP provides user identity and authentication.

21 - 20 BeneVision N1 Patient Monitor Operator’s Manual

The MLDAP server is connected with the hospital LDAP server. All monitoring devices are connected to the

MLDAP server to implement identity and authentication for the following operations:

Changing alarm settings

Changing arrhythmia settings

Accessing the Maintenance dialog

21.13.1

Setting MLDAP

To access the MLDAP server, you should set your monitor as follows:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Network Setup tab

MLDAP tab.

3.

Set Server address and port of the MLDAP server.

21.13.2

Testing MLDAP Server Connection

To test whether the monitor is properly connected with the MLDAP server, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Network Setup tab → MLDAP tab.

3.

Select Network Test .

21.13.3

Selecting Password for User Authentication

You can select what password is used when changing alarm settings, arrhythmia settings, and accessing the

Maintenance dialog. To do so, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Authorization Setup tab.

3.

From the Maintenance area, set User Maintenance to select the password for accessing the monitor’s

Maintenance dialog.

◆ Local Password : the monitor’s password for accessing the Maintenance dialog is required.

◆ User Password : the user name and password saved in the MLDAP server are required.

4.

From the Others area, set Alarm Setup : select the password for changing alarm settings.

◆ No Password : changing alarm settings is not password protected.

◆ Local Password : changing alarm switch, alarm limit, and alarm priority is password protected. The monitor’s password for changing alarm settings is required.

◆ User Password : changing alarm switch, alarm limit, and alarm priority is password protected. The user name and password saved in the MLDAP server are required.

5.

Set Arrhythmia : select the password for changing arrhythmia settings.

◆ No Password : changing arrhythmia settings is not password protected.

◆ Local Password : changing arrhythmia switch, alarm priority, and arrhythmia threshold is password protected. The monitor’s password for changing arrhythmia settings is required.

◆ User Password : changing arrhythmia switch, alarm priority, and arrhythmia threshold is password protected. The user name and password saved in the MLDAP server are required.

From the Maintenance area, selecting Modify Local Password can change the monitor’s password for accessing the Maintenance dialog.

From the Others area, selecting Modify Local Password can change the monitor’s password for accessing alarm settings and arrhythmia settings.

BeneVision N1 Patient Monitor Operator’s Manual 21 - 21

21.13.4

Setting the Password Timeout Period

If you use the password saved in the MLDAP server to access the Maintenance dialog, alarm settings and arrhythmia settings, you can set the password timeout period. Once the timeout period is reached, you will need to re-enter the password. To do so, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Authorization Setup tab.

3.

Set Retention Time .

21.14

Setting the Dock

After the N1 is transferred to the target location, connecting the N1 to a Dock enables N1 to use the settings of the Dock. All the settings in this section are stored in the Dock. When the N1 is disconnected from the Dock, the

N1 uses its own settings and network.

21.14.1

Setting the Work Mode

To set the work mode of the Dock, follow this procedure:

1.

Connect the N1 to the Dock.

2.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

select .

3.

Select the Dock Setup tab

→ select the Setup tab.

4.

Set the Work Mode . The default work mode is Dock Mode .

◆ Dock Mode : the patient location settings (facility, department, room number, and bed number), printer settings, and authorization settings are from the N1. You can change these settings on Device

Location , Print , or Authorization Setup page from the Maintenance menu.

◆ Host Mode : the patient location settings (facility, department, room number, and bed number), printer settings, and authorization settings are from the Dock. You can change these settings on

Location , Printer , or Authorization Setup tab from the Dock Setup page.

21.14.2

Setting the Net Setting Type

To set the network setting type of the Dock, follow this procedure:

1.

Connect the N1 to the Dock.

2.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

3.

Select the Dock Setup tab → select the Setup tab.

4.

Set the Net Setting Type . The default work mode is Use current N1 net setting .

◆ Use current N1 net setting : the IP and WLAN settings are from the N1. You can change these settings on Network Setup page from the Maintenance menu.

◆ Use current Dock net setting : the IP and WLAN settings are from the Dock. You can change these settings on IP , or WLAN tab from the Dock Setup page.

21.14.3

Setting the Network of the Dock

21.14.3.1 Selecting a Network Type

To select network type, follow this procedure:

1.

Connect the N1 to the Dock.

2.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

3.

Select the Dock Setup tab

select the Setup tab.

4.

Set the Work Mode to Host Mode .

21 - 22 BeneVision N1 Patient Monitor Operator’s Manual

5.

Select the IP tab.

6.

Set Network Type to LAN1 IP , or WLAN according to your network type.

21.14.3.2 Setting the Wired Network

Wired networking is available as long as N1 is connected to the Dock. To set the wired network, follow this procedure:

1.

Connect the N1 to the Dock.

2.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

3.

Select the Dock Setup tab

select the Setup tab.

4.

Set the Work Mode to Host Mode .

5.

Select the IP tab.

6.

Set Network Type to LAN1 IP .

7.

Select how to get the IP address of wired network.

Obtain IP Address Automatically : the monitor automatically gets the IP address.

Use the Following Address : you need to input the IP address , Subnet mask , and Gateway .

8.

Select how to get the DNS address:

Obtain DNS Address Automatically : the monitor automatically gets the DNS address.

Use the following DNS Address : you need to input the IP address of Preferred DNS server and

Alternate DNS server .

21.14.3.3 Setting the Wireless Network

To set the wireless network of the Dock, follow this procedure:

1.

Connect the N1 to the Dock.

2.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

3.

Select the Dock Setup tab → select the Setup tab.

4.

Set the Work Mode to Host Mode .

5.

Select the IP tab, and set Network Type to WLAN .

6.

Select how to get the IP address of wireless network.

◆ Obtain IP Address Automatically : the monitor automatically gets the IP address.

◆ Use the Following Address : you need to input the IP address , Subnet Mask , and Gateway .

7.

Select how to get the DNS address:

◆ Obtain DNS Address Automatically : the monitor automatically gets the DNS address.

◆ Use the following DNS Address : you need to input the IP address of Preferred DNS server and

Alternate DNS server .

8.

Select the WLAN tab and set SSID , Security , and Password .

After configuring the wireless network, select Network Test to verify that the wireless network can be properly connected.

21.14.4

Setting the External Display

To set the external display, follow this procedure:

1.

Connect the N1 to the Dock.

2.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

3.

Select the Dock Setup tab → select the Setup tab.

4.

Set the External Screen Contents .

BeneVision N1 Patient Monitor Operator’s Manual 21 - 23

◆ Mirrored : the contents of the external display is exactly the same with the monitor.

◆ Independent : separately configure the contents and layout of the monitor and external display.

NOTE

The N1’s screen and the independent external display’s screen cannot be viewed simultaneously. To switch the viewing location between the N1's screen and the independent external display, gently press the power switch of the N1, or double click on the screen to be viewed.

In the situation that the External Screen Content is set to Independent and the viewing location is switched to the N1, if there is no operation on the monitor within one minute, the viewing location will automatically switch back to the external display.

21.15

Defining Other Functions

21.15.1

Setting Notch Filter Frequency

Set notch filter frequency according to the power line frequency of your country. To set notch filter frequency, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password

→ select .

2.

Select the Other tab.

3.

Set Notch Frequency to 50 Hz or 60 Hz according to the power line frequency.

21.15.2

Setting Mouse Sensitivity

The mouse sensitivity is adjustable. To do so, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password

select .

2.

Select the Other tab.

3.

Set Mouse Sensitivity .

21.15.3

Setting the SpO

2

Tone Mode

The monitor adjusts the QRS tone (pitch tone) according to the SpO

2

values. To set the SpO

2

tone mode, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Other tab.

3.

Set SpO2 Tone to Mode 1 or Mode 2 . The pitch changes more rapidly in Mode 2 than in Mode 1, as saturation levels change.

The SpO

2

tone mode chart for SpO

2

between 40% to 100% is as follows:

21 - 24 BeneVision N1 Patient Monitor Operator’s Manual

CAUTION

It is highly recommended to use the same SpO

2

tone mode for the same monitors in a single area to prevent issues arising from inconsistent operation.

21.15.4

Selecting the Language

To set the user interface (UI) language, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Other tab

3.

Set Language .

21.15.5

Switching On or Off a Parameter

If there is no Parameters On/Off tab in the Screen Setup dialog then setting parameter switches is password protected. Follow this procedure to set parameter switches:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Other tab.

3.

Select Parameters On/Off .

4.

Enable or disable desired parameters.

When a parameter is switched off, the monitor stops data acquisition and alarming for this measurement.

NOTE

When a parameter is manually switched off and the corresponding parameter module is plugged in, you cannot monitor this parameter.

21.15.6

Setting If Setting Parameter Switches is Protected

You can set whether setting parameter switches is password protected. To do so, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Other tab.

3.

Switch on or off Parameters On/Off Protected .

BeneVision N1 Patient Monitor Operator’s Manual 21 - 25

21.15.7

Setting If Parameter Switch is Influenced by Configuration

You can set if the settings of parameter switches are influenced by loading a configuration. To do so, follow this procedure:

1.

Select the Main Menu quick key → from the System column select Maintenance → input the required password

→ select .

2.

Select the Other tab.

3.

Switch on or off Parameters On/Off Config Influenced .

21.15.8

Setting the Outdoor Mode

To set the way of entering the outdoor mode, follow this procedure:

1.

Select the Main Menu quick key

from the System column select Maintenance

input the required password → select .

2.

Select the Other tab.

3.

Set Enter Outdoor Mode to Manual or Auto .

◆ Manual : The monitor enters the outdoor mode by manually selecting the Main Menu quick key → from the Display column select Enter Outdoor Mode .

◆ Auto : The monitor enters the outdoor mode automatically if the strength of ambient light is greater than the threshold.

21 - 26 BeneVision N1 Patient Monitor Operator’s Manual

22

Battery

22.1

Battery Introduction

This monitor is designed to run on rechargeable Lithium-ion battery power when the external power is not available. The monitor can switch between battery power and the external power without interrupting patient monitoring. If both the external power and the battery power are available, the monitor uses the external power in preference to the battery power.

This monitor is designed to operate on battery power when the mains power is not available. The monitor uses mains power as primary power source. In case of mains power failure, the monitor automatically runs on the battery power.

22.2

Battery Safety Information

WARNING

Keep batteries out of the reach of children.

Use only Mindray specified batteries. Use of a different battery may present a risk of fire or explosion.

Keep the batteries in their original package until you are ready to use them.

Do not expose batteries to liquid.

Do not crush, drop or puncture the battery. Mechanical abuse can lead to internal damage and internal short circuits. If a battery has been dropped or banged against a hard surface, whether damage is externally visible or not, remove the battery from use and dispose of it properly.

If the battery shows signs of damage or signs of leakage, replace it immediately. Use caution in removing the battery. Avoid contacting the leakage.

Batteries should be charged only in this monitor.

Extremely high ambient temperature may cause battery overheat protection, resulting in monitor shutdown.

The lithium-ion battery has a service life. Replace the battery when it reaches the end of its service life. Failure to replace the battery may cause serious damage to the equipment from battery overheating.

Do not open batteries, heat batteries above 60 °C, incinerate batteries, or short battery terminals.

They may ignite, explode, leak or heat up, causing personal injury.

CAUTION

Remove the battery if it will not be used for an extended period of time.

22.3

Installing the Battery

The battery must only be installed by service personnel trained and authorized by Mindray. To install the battery, contact your service personnel. The battery is installed when the monitor leaves the factory.

22.4

Battery Indications

The battery LED, on-screen battery symbol, battery power indicator, and related alarm messages indicate the battery status.

BeneVision N1 Patient Monitor Operator’s Manual 22 - 1

22.4.1

Battery LED

The battery LED lies on the lower right corner of the monitor front panel.

BeneVision N1

The battery LED indications are as follows:

Green: the battery is fully charged.

Yellow: the battery is being charged.

Flashing green: the monitor is running on battery power.

Flashing yellow: the battery is malfunctioning.

Off: no battery is installed, or the monitor is powered off and no external power is connected.

22.4.2

Battery symbols

The on-screen battery symbols indicate the battery status as follows:

■ indicates that the battery is working correctly. The green portion represents the remaining charge.

indicates that the battery power is low and needs to be charged.

indicates that the battery is almost depleted and needs to be charged immediately. Otherwise, the monitor will automatically shut down soon.

indicates that the battery is being charged.

indicates that no battery is installed.

indicates a battery fault, battery communication fault, or battery charging fault. Contact service personnel for help.

22.4.3

Battery Power Indicator

Battery power indicator displays the remaining battery power.

22.4.4

Battery-related Alarms

The capacity of the battery is limited. When the battery level is low, the monitor presents the Low Battery alarm, the alarm lamp flashes, and the monitor produces an alarm sound.

If the battery is almost depleted, the monitor presents the Critically Low Battery alarm. In this case, immediately connect the external power to the monitor and charge the battery. Otherwise, the monitor will automatically shut down soon.

22 - 2 BeneVision N1 Patient Monitor Operator’s Manual

If the battery has been used for a prolonged period of time, the battery will be aged and its runtime may be significantly less than the specification. If the battery is aged, the Battery Service Required alarm is presented each time the monitor is turned on, indicating that the battery has reached its end of life.

For more information on battery-related alarms, see Appendix D Alarm Messages .

22.5

Charging the Battery

To optimize performance, a fully (or nearly fully) discharged battery should be charged as soon as possible. The battery can be charged in any of the following methods:

Method 1: the monitor is connected to the AC adapter or Dock.

Method 2: the monitor is in use with a host monitor.

Method 3: the monitor is in use with the Transport Dock.

For method 1 and method 3, the battery is charged regardless of whether or not the monitor is currently turned on. For method 2, the host monitor must be powered on for the N1 monitor's battery to charge.

22.6

Maintaining the Battery

22.6.1

Conditioning the Battery

The performance of the battery deteriorates over time. You should condition the battery every three months. If the battery is not conditioned for a prolonged time, its charge indication may not be accurate and you may wrongly evaluate the remaining battery runtime.

To condition a battery, follow this procedure:

1.

Disconnect the monitor from the patient and stop all monitoring and measuring procedures.

2.

Turn off the monitor, and connect the monitor to the external power source.

3.

Allow the battery to be charged uninterruptedly until it is fully charged.

4.

Disconnect the monitor from the external power source, and turn on the monitor.

5.

Allow the monitor to run on the battery until the battery is completely depleted and the monitor automatically shuts down.

6.

Fully charge the battery again for use or charge it to 40 - 60% for storage.

NOTE

Do not use the monitor to monitor a patient during battery conditioning.

Do not interrupt battery conditioning. Interrupting battery conditioning to use the monitor will prevent completion of the conditioning cycle and require repeating the conditioning process completely to properly condition the battery.

22.6.2

Checking Battery Performance

Life expectancy of a battery depends on how frequent and how long it is used. When properly used, the lithiumion battery has a useful life of approximately two years. If improperly used, its life expectancy can be shorter. We recommend replacing the lithium-ion battery every two years.

The performance of a rechargeable battery deteriorates over time. You should check the battery performance every two months or if you question it is meeting the product specifications.

See steps 1 to 5 of

22.6.1 Conditioning the Battery

to check battery performance. The operating time of the batteries reflects their performance directly. If the operating time of a battery is noticeably shorter than that stated in the specifications, the battery may have reached its service life or be malfunctioning. If the battery performance meets the requirement, fully charge the battery again for use or charge it to 40 - 60% for storage.

NOTE

Battery operating time depends on equipment configuration and operation. For example, high display brightness or measuring NIBP repeatedly will shorten the battery operating time.

BeneVision N1 Patient Monitor Operator’s Manual 22 - 3

22.7

Storing Batteries

When storing batteries, make sure that the battery terminals do not come into contact with metallic objects. If batteries are stored for an extended period of time, place the batteries in a cool place with a partial charge of

40% to 60% capacity.

Condition the stored batteries every three months. For more information, see 22.6.1 Conditioning the Battery .

NOTE

Remove the battery from the equipment if the equipment is not used for a prolonged time (for example, several weeks). Otherwise the battery may overdischarge.

Storing batteries at high temperature for an extended period of time will significantly shorten their life expectancy.

Storing batteries in a cool place can slow the aging process. Ideally the batteries should be stored at

15 °C.

22.8

Recycling Batteries

Discard a battery in the following situations:

The battery has visual signs of damage.

The battery fails.

The battery is aged and its runtime significantly less than the specification.

The battery has been used for more than it service time.

Properly dispose of batteries according to local regulations.

WARNING

Do not open batteries, heat batteries above 60 °C, incinerate batteries, or short the battery terminals. They may ignite, explode, leak or heat up, causing personal injury.

22 - 4 BeneVision N1 Patient Monitor Operator’s Manual

23

Care and Cleaning

23.1

Care and Cleaning Introduction

In this chapter we only describe cleaning and disinfection of the main unit, parameter modules, mounting kits, and certain parameter accessories. For the cleaning and disinfection of the Transport Dock and other reusable accessories, refer to their instructions for use of the corresponding accessories.

Keep your equipment and accessories clean. To avoid damage to the equipment, follow these guidelines:

Always follow the manufacturer’s instructions for each cleaning / disinfecting agent.

Do not immerse any part of the equipment or accessories into liquid.

Do not pour liquid onto the equipment or accessories.

Do not allow liquid to enter the case.

Never use abrasive materials (such as steel wool or silver polish), or erosive cleaners (such as acetone or acetone-based cleaners).

23.2

Care and Cleaning Safety Information

WARNING

Be sure to turn off the system and disconnect all power cables from the outlets before cleaning the equipment.

CAUTION

If you spill liquid on the equipment or accessories, contact Mindray or your service personnel.

Avoid wetting the pins and metal parts of the equipment, mounting kits or accessories during cleaning and disinfection.

Use only Mindray approved cleaners and disinfectants and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by unapproved substances or methods.

We make no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. For the method to control infection, consult your hospital’s Infection Control

Officer or Epidemiologist.

The responsible hospital or institution shall carry out all cleaning and disinfection procedures specified in this chapter.

Refer to the respective instructions for use of the cleaning agents and disinfectants.

Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gases may result.

NOTE

To clean or disinfect reusable accessories, refer to the instructions delivered with the accessories.

BeneVision N1 Patient Monitor Operator’s Manual 23 - 1

23.3

Cleaning and Disinfecting the Equipment and Mounting Kits

Use approved cleaning and disinfecting agents for cleaning or disinfecting the main unit, parameter modules,

Modular Rack, Dock, folding hook, monitor handle, and bedrail hook.

23.3.1

Approved Cleaning and Disinfecting Agents

The following table lists approved cleaning and disinfecting agents:

:

Product Name Product Type Active Ingredients

Liquid Sodium hypochlorite bleach

Hydrogen peroxide

Isopropanol

1-Propanol

Metrex CaviCide1™

Virex® II 256 (1:256)

Virex® TB

Rely+OnTM Virkon® High Level

Surface Disinfectant

Alpet® D2 Surface Sanitizing

Wipes

Powder

Wipes

Sodium hypochlorite bleach 0.5%

Hydrogen peroxide 3%

Isopropanol 70%

1-Propanol 50%

Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride 0.28%,

Isopropanol 17.2%

Didecyl dimethyl ammonium chloride 8.704%, n-Alkydimethyl benzyl ammonium chloride 8.190% n-Alkyl dimethyl benzyl ammonium chlorides 0.105%, n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.105%

Used as 1% solution

Biocidal active:

Pentapotassium bis (peroxymonosulphate) bis (sulphate)(500g/ kg),

Contains dipotassium peroxodisulphate.

Isopropyl Alcohol 58.6000%,

Octyl Decyl Dimethyl Ammonium chloride 0.0075%,

Dioctyl Dimethyl Ammonium Chloride 0.0030%

Sodium Hypochlorite 0.65% Clorox Dispatch® Hospital

Cleaner Disinfectant Towels with

Bleach

Clorox Healthcare® Bleach

Germicidal Wipes

Clorox Healthcare® Hydrogen

Peroxide Cleaner Disinfectant

Wipes

Diversey Oxivir® TB Wipes

Metrex CaviWipes™

Sodium Hypochlorite 0.55%

Hydrogen Peroxide 1.4%

Hydrogen Peroxide 0.5%

Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride 0.28%,

Isopropanol 17.2% n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.14%, n-Alkyl dimethyl benzyl ammonium chlorides 0.14%

Sodium Hypochlorite 0.63%,other ingredients 99.37%

PDI Sani-Cloth® AF3 Germicidal

Disposable Wipe

PDI Sani-Cloth® Bleach

Germicidal Disposable Wipe

PDI Sani-Cloth® HB Germicidal

Disposable Wipe

PDI Sani-Cloth® Plus Germicidal

Disposable Cloth

PDI Super Sani-Cloth® Germicidal

Disposable Wipe n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.07%, n-Alkyl dimethyl benzyl ammonium chlorides 0.07% n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.125%, n-Alky dimethyl benzyl ammonium chlorides 0.125% n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.25%, n-Alkyl dimethyl benzyl ammonium chlorides 0.25%,

Isopropyl Alcohol 55.0%

23 - 2 BeneVision N1 Patient Monitor Operator’s Manual

Product Name

VIRAGUARD Hospital Surface

Disinfectant Towelettle

Product Type

Wipes

Active Ingredients

Isopropanol 70%,

Other ingredients 30%

NOTE

For equipment with the symbol , all the listed cleaning and disinfecting agents are available for use.

23.3.2

Cleaning the Equipment and Mounting Kits

The main unit, parameter modules, Modular Rack, Dock, folding hooks, monitor handle, and bedrail hooks should be cleaned on a regular basis. Before cleaning the equipment and mounting kits, consult your hospital’s regulations for cleaning the equipment.

To clean your equipment, follow this procedure:

1.

Shut down the monitor and disconnect it from the AC power.

2.

Clean the display screen with wipes or a soft cloth moistened with one of the cleaning agents listed in

23.3.1 Approved Cleaning and Disinfecting Agents only.

3.

Clean the exterior surface of the equipment and mounting kits with wipes or a soft cloth moistened with

one of the cleaning agents listed in 23.3.1 Approved Cleaning and Disinfecting Agents

only.

4.

Wipe off all the cleaning agent residue with a dry cloth.

5.

Dry your equipment in a ventilated, cool place.

23.3.3

Disinfecting the Equipment and Mounting Kits

Disinfect the main unit, parameter modules, Modular Rack, Dock, folding hook, monitor handle, and bedrail hook as required in your hospital’s servicing schedule using the disinfecting agents listed in the table above.

Cleaning equipment and mounting kits before disinfecting is recommended.

CAUTION

Never use EtO or formaldehyde for disinfection.

23.4

Cleaning and Disinfecting the Accessories

For the NIBP air hose and SpO

2

cable, you should clean and disinfect them using the cleaners and disinfectants and methods listed in this section. For other accessories, you should consult the instructions delivered with the accessories.

CAUTION

Fluids entering the NIBP air hose can damage the equipment. When cleaning and/or disinfecting the

NIBP air hose, prevent liquid from entering the hose.

Periodically inspect the NIBP air hose and connector for signs of wear or deterioration. Replace the

NIBP air hose if you detect a leak. Dispose of damaged NIBP air hose according to local laws for disposal of hospital waste.

Never immerse or soak the accessories in any liquid.

Never clean or disinfect the metalic connectors at either end of the accessories.

Use only Mindray approved cleaners and disinfectants and methods listed in this section to clean or disinfect the accessories. Warranty does not cover damage caused by unapproved substances or methods.

To avoid long term damage, the accessories should be disinfected only when necessary as determined by your hospital’s policy.

BeneVision N1 Patient Monitor Operator’s Manual 23 - 3

23.4.1

Approved Accessories Cleaning and Disinfecting Agents

The following table lists approved NIBP air hose cleaning and disinfecting agents:

:

Product Name Product Type Active Ingredients

Isopropanol

1-Propanol

Metrex CaviCide1™

Virex® TB

Rely+OnTM Virkon® High Level

Surface Disinfectant

Alpet® D2 Surface Sanitizing

Wipes

Liquid

Powder

Wipes

Isopropanol 70%

1-Propanol 50%

Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride 0.28%,

Isopropanol 17.2% n-Alkyl dimethyl benzyl ammonium chlorides 0.105%, n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.105%

Used as 1% solution

Biocidal active:

Pentapotassium bis (peroxymonosulphate) bis (sulphate)(500g/ kg),

Contains dipotassium peroxodisulphate.

Isopropyl Alcohol 58.6000%,

Octyl Decyl Dimethyl Ammonium chloride 0.0075%,

Dioctyl Dimethyl Ammonium Chloride 0.0030%

Sodium Hypochlorite 0.65% Clorox Dispatch® Hospital

Cleaner Disinfectant Towels with

Bleach

Metrex CaviWipes™

PDI Sani-Cloth® AF3 Germicidal

Disposable Wipe

PDI Sani-Cloth® Plus Germicidal

Disposable Cloth

PDI Super Sani-Cloth® Germicidal

Disposable Wipe

VIRAGUARD Hospital Surface

Disinfectant Towelettle

Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride 0.28%,

Isopropanol 17.2% n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.14%, n-Alkyl dimethyl benzyl ammonium chlorides 0.14% n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.125%, n-Alky dimethyl benzyl ammonium chlorides 0.125% n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.25%, n-Alkyl dimethyl benzyl ammonium chlorides 0.25%,

Isopropyl Alcohol 55.0%

Isopropanol 70%,

Other ingredients 30%

:

The following table lists approved Masimo SpO

2

cable cleaning and disinfecting agents:

Product Name Product Type Active Ingredients

Isopropanol Liquid Isopropanol 70%

23 - 4 BeneVision N1 Patient Monitor Operator’s Manual

:

The following table lists approved Nellcor SpO

2

cable cleaning and disinfecting agents:

Product Name Product Type Active Ingredients

Liquid Sodium hypochlorite bleach

Isopropanol

1-Propanol

Virex® TB

Rely+OnTM Virkon® High Level

Surface Disinfectant

Powder

Sodium hypochlorite bleach 0.5%

Isopropanol 70%

1-Propanol 50% n-Alkyl dimethyl benzyl ammonium chlorides 0.105%, n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.105%

Used as 1% solution

Biocidal active:

Pentapotassium bis (peroxymonosulphate) bis (sulphate)(500g/ kg),

Contains dipotassium peroxodisulphate.

Sodium Hypochlorite 0.65% Clorox Dispatch® Hospital

Cleaner Disinfectant Towels with

Bleach

Clorox Healthcare® Bleach

Germicidal Wipes

Clorox Healthcare® Hydrogen

Peroxide Cleaner Disinfectant

Wipes

Diversey Oxivir® TB Wipes

PDI Super Sani-Cloth® Germicidal

Disposable Wipe

Wipes

VIRAGUARD Hospital Surface

Disinfectant Towelettle

Sodium Hypochlorite 0.55%

Hydrogen Peroxide 1.4%

Hydrogen Peroxide 0.5% n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.25%, n-Alkyl dimethyl benzyl ammonium chlorides 0.25%,

Isopropyl Alcohol 55.0%

Isopropanol 70%,

Other ingredients 30%

23.4.2

Cleaning the Accessories

You should clean the accessories (NIBP air hose and SpO

2

cable) on a regular basis. Before cleaning the accessories, consult your hospital’s regulations for cleaning the accessories.

To clean the accessories, follow this procedure:

1.

Clean the accessories with wipes or a soft cloth moistened with one of the cleaning agents listed in

23.4.1 Approved Accessories Cleaning and Disinfecting Agents

only.

2.

Wipe off all the cleaning agent residue with a dry cloth.

3.

Allow the accessories to air dry.

23.4.3

Disinfecting the Accessories

We recommend that the accessories (NIBP air hose and SpO

2

cables) should be disinfected only when necessary as determined by your hospital’s policy, to avoid long term damage to the accessories. Cleaning the accessories before disinfecting is recommended.

23.5

Sterilization

Sterilization is not recommended for this equipment, related products, accessories, or supplies unless otherwise indicated in the Instructions for Use that accompany the products, accessories or supplies.

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23 - 6 BeneVision N1 Patient Monitor Operator’s Manual

24

Maintenance

24.1

Maintenance Introduction

Regular maintenance is essential to ensure that the equipment continues to function properly. This chapter contains information on periodic testing and maintenance.

24.2

Maintenance Safety Information

WARNING

To avoid electric shock, stop using the equipment if you find the housing is damaged, and contact the service personnel.

Failure on the part of the responsible individual hospital or institution using this equipment to implement a recommended maintenance schedule may cause undue equipment failure and possible health hazards.

No modification of this equipment is allowed.

This equipment contains no user serviceable parts.

The safety checks or maintenance involving any disassembly of the equipment should be performed by professional service personnel. Otherwise, undue equipment failure and possible health hazards could result.

Do not open batteries, heat batteries to above 60 °C, incinerate batteries, or short the battery terminals. Batteries may ignite, explode, leak or heat up, causing personal injury.

The service personnel must be properly qualified and thoroughly familiar with the operation of the equipment.

CAUTION

The equipment and accessories shall not be serviced or maintained while in use on a patient.

If you discover a problem with any of the equipment, contact your service personnel or Mindray.

Use and store the equipment within the specified temperature, humidity, and altitude ranges.

When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of the reach of children.

At the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the equipment, please contact Mindray.

BeneVision N1 Patient Monitor Operator’s Manual 24 - 1

24.3

Maintenance and Testing Schedule

Follow the maintenance and testing schedule or local regulations to perform testing and maintenance such as defined in section

24.5 Testing Methods and Procedures

. Follow your hospital policy on cleaning and disinfecting the equipment before testing and maintenance.

The following table lists the maintenance and testing schedule:

Test/Maintenance Item

Performance Tests

Visual inspection

Measurement module performance test and calibration

Analog output test

Defibrillation synchronization test

Electrical Safety Tests

Electrical safety tests

Other Tests

Power-on test

Network printer tests

Battery check Functionality test

Performance test

Recommended Frequency

Every day, before first use.

1. If you suspect that the measurement values are incorrect.

2. Follow any repairs or replacement of relevant module.

3. Once a year for CO

2

tests.

4. Once every two years for other parameter module performance tests.

If you suspect that the analog output function does not work properly.

If you suspect that the defibrillation synchronization function does not work properly.

Once every two years.

Before use

1. When first installed.

2.Follow any repair or replacement of the printer.

1. When first installed.

2. When battery is replaced.

Every three months or if the battery runtime is reduced significantly.

24.4

Checking System Software Version

To view system software version information, select the Main Menu quick key

from the System column select

Version .

You can check the detailed system software version, module hardware and software version, and firmware version only from the Maintenance dialog.

24.5

Testing Methods and Procedures

Except for the following maintenance tasks, all other test and maintenance tasks should be performed by

Mindray-qualified service personnel only.

Regular checks, including visual inspection and power-on test

Printer tests

Battery check

If your monitor needs a safety test and performance test, contact the service personnel.

24.5.1

Performing Visual Inspection

Visually inspect the equipment before its first use every day. If you find any signs of damage, remove the monitor from use and contact the service personnel.

24 - 2 BeneVision N1 Patient Monitor Operator’s Manual

Verify that the equipment meets the following requirements:

Environment and power supply specifications are met.

The monitor housing and display screen are free from cracks or other damage.

The power cord is not damaged and the insulation is in good condition.

Connectors, plugs, and cables are not damaged or kinked.

Power cord and patient cables are securely connected to the equipment and modules.

24.5.2

Performing Power-on Test

The monitor automatically performs a power-on test at startup. Verify the following items for the power-on test:

The equipment powers on properly.

The alarm system works properly, denoted by alarm sounds and display of all 3 alarm light colors.

The monitor displays properly.

24.5.3

Testing the Network Printer

To check the printer, follow this procedure:

1.

Start a printing task to print waveforms and reports.

2.

Check that the printer is properly connected and functions correctly.

3.

Check that the printout is clear with no missing information.

24.5.4

Checking the Battery

For information on battery check, see 22.6.2 Checking Battery Performance

.

24.6

NIBP Maintenance

24.6.1

NIBP Leakage Test

The NIBP leakage test checks the integrity of the system and of the valve. The NIBP leakage test should be performed once every two years or when you doubt the NIBP measurements. The NIBP leakage test should be performed by Mindray-qualified service personnel only.

24.6.2

NIBP Accuracy Test

The NIBP accuracy test should be performed once every two years or when you doubt the NIBP measurements.

The NIBP accuracy test should be performed by Mindray-qualified service personnel only.

24.7

Disposing of the Monitor

Dispose of the monitor and its accessories when its service life is reached. Follow local regulations regarding the disposal of such product.

WARNING

For disposal of parts and accessories, where not otherwise specified, follow local regulations regarding disposal of hospital waste.

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24 - 4 BeneVision N1 Patient Monitor Operator’s Manual

25

Accessories

The accessories listed in this chapter comply with the requirements of IEC 60601-1-2 when in use with the patient monitor. The accessory material that contacts the patients has undertaken the bio-compatibility test and is verified to be in compliance with ISO 10993-1. For details about the accessories, refer to the instructions for use provided with the accessory.

WARNING

Use accessories specified in this chapter. Using other accessories may cause damage to the patient monitor or not meet the claimed specifications.

Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy.

CAUTION

The accessories may not meet the performance specifications if stored or used outside the specified temperature and humidity ranges. If accessory performance is degraded due to aging or environmental conditions, contact your service personnel.

Check the accessories and their packages for any sign of damage. Do not use them if any damage is detected.

Use the accessories before the expiration date if an expiration date is indicated.

Discard disposable accessories according to hospital regulations.

NOTE

This manual describes all the accessories that are validated for use. Not all accessories are available in every market.

25.1

ECG Accessories

25.1.1

ECG Electrodes Available for Purchase

Model Part No.

31499224 0010-10-12304

1050NPSMKittycat 0681-00-0098-01

1051NPSMKittycat 0681-00-0098-02

Description

Electrode, Kendall, pkg of 10

NEO pre-wired electrode radio

Opaque, pkg of 100

NEO pre-wired electrode radio

Translucent, pkg of 100

25.1.2

ECG Electrodes Also Compatible

Model

2245-50

Part No.

9000-10-07469

Description

ECG electrode, 3M, pkg of 50

Usage

Disposable

Disposable

Disposable

Applicable patient

Adult

Neonate

Neonate

Usage

Disposable

Applicable patient

Pediatric

BeneVision N1 Patient Monitor Operator’s Manual 25 - 1

25.1.3

12-Pin Trunk Cables Available for Purchase

Model

EV6206

EV6207

EV6216

EV6217

EV6208

Part No.

009-005266-00

009-005267-00

009-005268-00

009-005269-00

040-003528-00

Description

ECG cable, 10' (3.1 m), defibrillation-proof, for N/T

ECG cable, 20' (6.2 m), defibrillation-proof, for N/T

ECG cable, 10' (3.1 m), ESU-proof, for N/T

ECG cable, 20' (6.2 m), ESU-Proof , for N/T

ECG cable, 10' (3.1 m), 12-lead, defibrillation-proof, for N/T 5-lead leadwires

Note: 040-003528-00 uses 5-Lead N/T leadwires for the limb leads.

Usage

Reusable

Reusable

Reusable

Reusable

Reusable

25.1.4

12-Pin Trunk Cables Also Compatible

Applicable patient

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

EV6211

EV6212

EV6222

/

/

Model

EV6201

EV6202

EV6203

Part No.

0010-30-42719

0010-30-42720

0010-30-42721

0010-30-42723

0010-30-42724

040-000754-00

040-001416-00

009-003652-00

Description

12Pin 3/5-Lead ECG trunk cable, defibrillation-proof

12Pin 3-Lead ECG trunk cable, defibrillation-proof

12Pin 12-Lead trunk cable, defibrillation-proof

12Pin 3/5-Lead ECG trunk cable,

ESU-proof

12Pin 3-Lead ECG trunk cable, ESUproof

12Pin 3-Lead trunk cable, defibrillation-proof, DIN Conn

12Pin 3/5-Lead ECG trunk cable, defibrillation-proof

12Pin 3/5-Lead ECG trunk cable,

ESU-proof

Usage

Reusable

Reusable

Reusable

Reusable

Reusable

Reusable

Reusable

Reusable

25.1.5

3-lead ECG Leadwires Available for Purchase

Model

EY6316B

EY6305B

EY6316A

EY6305A

EY6310B

EY6310B

Part No.

009-004765-00

009-004766-00

009-004771-00

009-004772-00

009-004777-00

115-032954-00

Description

3-Lead, N/T, AHA, snap, 24’’

3-Lead, N/T, AHA, snap, 36’’

3-Lead, N/T, AHA, clip, 24’’

3-Lead, N/T, AHA, clip, 36’’

3-Lead, N/T, AHA, snap, 24’’

3-Lead, N/T, AHA, snap, 24’’, pkg of

20

Usage

Reusable

Reusable

Reusable

Reusable

Disposable

Disposable

Applicable patient

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Applicable patient

Adult/Pediatric

Pediatric/Neonate

Adult/Pediatric

Adult/Pediatric

Pediatric/Neonate

Pediatric/Neonate

Adult/Pediatric

Adult/Pediatric

25 - 2 BeneVision N1 Patient Monitor Operator’s Manual

25.1.6

3-lead ECG Leadwires Also Compatible

Model

EL6305A

EL6303A

EL6301B

EL6311B

EL6311A

/

/

/

/

Part No.

0010-30-42896

0010-30-42731

0010-30-42734

040-000146-00

040-000148-00

0012-00-1503-05

0012-00-1503-06

0012-00-1514-05

0012-00-1514-06

Description Usage

3-Lead leadset, AHA, clip

3-Lead leadset, AHA, clip, Long

3-Lead leadset, AHA, snap

3-Lead leadset, AHA, snap

3-Lead leadset, AHA, clip

3-Lead leadset, snap, 24" (61.0 cm),

AAMI

3-Lead leadset, snap, 36" (101.6 cm), AAMI

3-Lead leadset, clip, 24" (61.0 cm),

AAMI

3-Lead leadset, clip, 36" (101.6 cm),

AAMI

Reusable

Reusable

Reusable

Disposable

Disposable

Reusable

Reusable

Reusable

Reusable

Applicable patient

Neonate

Adult/Pediatric

Adult/Pediatric

Pediatric/Neonate

Pediatric/Neonate

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

25.1.7

5-lead ECG Leadwires Available for Purchase

Model

EY6511B

EY6512B

EY6511A

EY6512A

EY6507B

EY6507B

Part No.

009-004782-00

009-004783-00

009-004786-00

009-004787-00

009-004790-00

115-032955-00

Description

5-Lead, N/T, AHA, snap, 24’’

5-Lead, N/T, AHA, snap, 36’’

5-Lead, N/T, AHA, pinch, 24’’

5-Lead, N/T, AHA, pinch, 36’’

5-Lead, N/T, AHA, snap, 24’’

5-Lead, N/T, AHA, snap, 24’’, pkg of

20

Usage

Reusable

Reusable

Reusable

Reusable

Disposable

Disposable

Applicable patient

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

25.1.8

5-lead ECG Leadwires Also Compatible

/

/

Model

EL6503A

EL6501B

EL6501A

/

/

Part No.

0010-30-42729

0010-30-42735

0010-30-42727

0012-00-1503-02

0012-00-1503-03

0012-00-1514-02

0012-00-1514-03

Description Usage

5-Lead leadset, AHA, clip, Long

5-Lead leadset, AHA, snap

5-Lead leadset, AHA, clip

5-Lead leadset, snap, 24" (61.0 cm),

AAMI

5-Lead leadset, snap, 36" (101.6 cm), AAMI

5-Lead leadset, clip, 24" (61.0 cm),

AAMI

5-Lead leadset, clip, 36" (101.6 cm),

AAMI

Reusable

Reusable

Reusable

Reusable

Reusable

Reusable

Reusable

Applicable patient

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

BeneVision N1 Patient Monitor Operator’s Manual 25 - 3

25.1.9

6-lead ECG Leadwires Available for Purchase

Model

EY6601B

EY6602B

EY6601A

EY6602A

Part No.

009-004794-00

009-004795-00

009-004798-00

009-004799-00

Description

6-Lead, N/T, AHA, snap, 24’’

6-Lead, N/T, AHA, snap, 36’’

6-Lead, N/T, AHA, pinch, 24’’

6-Lead, N/T, AHA, pinch, 36’’

25.1.10

12-lead ECG Chest Leadwires Available for Purchase

Usage

Reusable

Reusable

Reusable

Reusable

Model

EL6803A

EL6803B

Part No.

0010-30-42904

0010-30-42908

Description

12-Lead leadset, chest, AHA, clip

12-Lead leadset, chest, AHA, snap

Usage

Reusable

Reusable

25.1.11

12-lead ECG Leadwires Also Compatible

Applicable patient

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Adult/Pediatric

Applicable patient

Adult/Pediatric

Adult/Pediatric

Model

EL6801A

EL6801B

Part No.

0010-30-42902

0010-30-42906

Description

12-Lead leadset, limb, AHA, clip

12-Lead leadset, limb, AHA, snap

Usage

Reusable

Reusable

25.2.2

Extension Cables and Adapter Cables Also Compatible

Model

582A

Part No.

115-020768-00

Description

8-pin SpO2 extension cable, Masimo

Usage

Reusable

Applicable patient

Adult/Pediatric

Adult/Pediatric

25.2

SpO

2

Accessories

Wavelength emitted by the sensors is between 600 nm and 1000 nm. The maximum photic output consumption of the sensor is less than 18 mW.

The information about the wavelength range and maximum photic output consumption can be especially useful to clinicians, for example, when photodynamic therapy is performed.

25.2.1

Extension Cables and Adapter Cables Available for Purchase

Model

572A

583A

4089

4092

Part No.

0010-20-42712

040-003310-00

040-003381-00

040-003426-00

Description

8-pin SpO2 extension cable, Nellcor

8 pin, RD SET, Masimo

RD to LNCS adapter cable, Masimo

LNCS to RD adapter, Masimo

Usage

Reusable

Reusable

Reusable

Reusable

Applicable patient

/

/

/

/

/

Applicable patient

25 - 4 BeneVision N1 Patient Monitor Operator’s Manual

25.2.3

Masimo SpO

2

RD Set Sensors Available for Purchase

4002

4003

4004

4005

Model

4050

4051

4053

4000

4001

Part No.

040-003376-00

040-003377-00

040-003380-00

040-003382-00

040-003383-00

040-003384-00

040-003385-00

040-003386-00

040-003387-00

Description Usage

SpO2 sensor, RD SET DCI

SpO2 sensor, RD SET DCI

SpO2 sensor, RD Set TC-I, tip-clip ear sensor, 3ft

SpO2 sensor, RD SET Adt, adhesive, pkg of 20

SpO2 sensor, RD SET PDT, adhesive, pkg of 20

SpO2 sensor, RD Set Inf, adhesive, pkg of 20

SpO2 sensor, RD Set Neo, adhesive, pkg of 20

SpO2 sensor, RD Set NeoPt, adhesive, pkg of 20

SpO2 sensor, RD Set NeoPt-500, nonadhesive, pkg of 20

Reusable

Reusable

Reusable

Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Applicable patient

Adult (> 30 kg)

Pediatric (10-50 kg)

Adult (> 30 kg)

Adult (> 30 kg)

Pediatric (10 to 50 kg)

Infant (3 to 20 kg)

Neonatal /Adult

(<3Kg or >40Kg)

Neonate (<1 kg)

Neonate (<1 kg)

25.2.4

Masimo SpO

2

LNCS Sensors Also Compatible

Model

LNCS Adtx

LNCS Pdtx

LNCS DCI

LNCS DCIP

LNCS NeoPt

LNCS Neo-L

Part No.

0600-00-0121

0600-00-0122

0600-00-0126

0600-00-0127

0600-00-0156

0600-00-0157

Description

SpO2 sensor, finger-clip, 20 pcs/box

SpO2 sensor, finger-clip, 20 pcs/box

SpO2 sensor, finger-clip

SpO2 sensor, finger-clip

SpO2 sensor, finger-clip

SpO2 sensor, 20 pcs/box

Usage

Disposable

Disposable

Reusable

Reusable

Disposable

Disposable

Disposable

Applicable patient

Adult (>30 kg)

Pediatric (10-50 kg)

Adult (>30 kg)

Pediatric (10-50 kg)

Neonate (<1Kg)

Neonate /Adult

(<3 kg or > 40 kg)

Infant (3-20 kg) LNCS Inf 0600-00-0158 SpO2 sensor, 20 pcs/box

25.2.5

Nellcor SpO

2

Sensors Also Compatible

Model

DS100A

D-YS

OXI-P/I

OXI-A/N

MAXAI

MAXPI

MAXII

Part No.

9000-10-05161

0010-10-12476

9000-10-07308

9000-10-07336

0010-10-12202

0010-10-12203

0010-10-12204

Description

SpO2 sensor, finger-clip

SpO2 sensor, with wraps

SpO2 sensor, finger, band

SpO2 sensor, finger/foot, band

SpO2 sensor, 24 pcs/box

SpO2 sensor, 24 pcs/box

SpO2 sensor, 24 pcs/box

Usage

Reusable

Reusable

Reusable

Reusable

Disposable

Disposable

Disposable

Applicable patient

Adult

/

Pediatric/Infant

Adult/Neonate

Adult (>30 kg)

Pediatric (10-50 Kg)

Infant (3-20 kg)

BeneVision N1 Patient Monitor Operator’s Manual 25 - 5

Model

MAXNI

Part No.

0010-10-12205

Description

SpO2 sensor, 24 pcs/box

Usage

Disposable

Applicable patient

Adult/Neonate

(<3 kg or >40 kg)

25.3

Temp Accessories

25.3.1

Temp Cable Available for Purchase

Model

MR420B

Part No.

040-001235-00

25.3.2

Temp Cable Also Compatible

Description

2-pin Temperature adapter cable

Usage

Reusable

Model

MR420B

Part No.

0011-30-37391

Description

2-pin, extension cable

25.3.3

Temp Probes Available for Purchase

Usage

Reusable

/

Applicable patient

/

Applicable patient

MR411

/

/

/

/

/

MR412

MR412

Model

MR401B

MR402B

MR403B

MR404B

MR411

Part No.

0011-30-37392

0011-30-37394

0011-30-37393

0011-30-37395

040-003292-00

040-003294-00

040-003293-00

040-003295-00

0206-03-0112-02

0206-03-0118-02

0206-03-0209-02

0206-03-0212-02

0206-03-0300-02

Description Usage

Temperature probe, endocavity

Temperature probe, endocavity

Temperature probe, skin surface

Temperature probe, skin surface

Temperature probe, esophageal/ rectal, 9FR

Temperature probe, esophageal/ rectal, 9FR, pkg of 20

Reusable

Reusable

Reusable

Reusable

Disposable

Disposable

Temp probe, skin surface Disposable

Temp probe, skin surface, pkg of 20 Disposable

PROBE,D TEMP,ES400-12 (box of 20) Disposable

PROBE,D TEMP,ES400-18 (box of 20) Disposable

PROBE,D TEMP,ER 400-9 (box of 20) Disposable

PROBE,D TEMP,ER400-12 (box of 20) Disposable

PROBE,D TEMP,STS-400 (box of 20) Disposable

Applicable patient

Adult

Pediatric/Infant

Adult

Pediatric/Infant

Adult/Pediatric

Adult/Pediatric

All

All

Adult

Adult

Adult

Adult

Adult

25.3.4

Temp Probes Also Compatible

Model

MR411

MR412

Part No.

0011-30-90446

0011-30-90447

Description

Disposable temperature probe, esophageal

Disposable temperature probe, skin

Usage

Disposable

Disposable

Applicable patient

All

All

25 - 6 BeneVision N1 Patient Monitor Operator’s Manual

25.4

NIBP Accessories

25.4.1

NIBP Hoses Available for Purchase

Model

CM1903

CM1901

Part No.

6200-30-09688

6200-30-11560

Description

NIBP hose, inbuilt connector, 3m

NIBP hose, inbuilt connector, 3m

Usage

Reusable

Reusable

25.4.2

Cuffs Available for Purchase

Applicable patient

Adult/Pediatric

Neonate

CM1504

CM1505

CM1506

CM1507

CM1500A

CM1500B

CM1500C

CM1500D

/

Model

CM1301

CM1302

CM1303

CM1304

CM1305

CM1306

CM1307

CM1501

CM1502

CM1503

115-027566-00

115-027567-00

115-027568-00

115-027569-00

001B-30-70692

001B-30-70693

001B-30-70694

001B-30-70695

115-031807-00

Part No.

115-027713-00

115-027714-00

115-027715-00

115-027716-00

115-027717-00

115-027718-00

115-027719-00

115-027563-00

115-027564-00

115-027565-00

Description

Cuff, 10-19 cm, bladderless

Cuff, 18-26 cm, bladderless

Cuff, 25-35 cm, bladderless

Cuff, 33-47 cm, bladderless

Cuff, 46-66 cm, bladderless

Cuff, 24-35 cm, bladderless

Cuff, 33-47 cm, bladderless

Cuff, 10-19 cm, bladderless, pkg of

10

Cuff, 18-26 cm, bladderless, pkg of

10

Cuff, 25-35 cm, bladderless, pkg of

10

Cuff, 33-47 cm, bladderless, pkg of

10

Cuff, 46-66 cm, bladderless, pkg of

5

Cuff, 25-35 cm, bladderless, pkg of

10, long

Cuff, 33-47 cm, bladderless, pkg of

10, long

Cuff, 3.1-5.7 cm, pkg of 20

Cuff, 4.3-8.0 cm, pkg of 20

Cuff, 5.8-10.9 cm, pkg of 20

Cuff, 7.1-13.1 cm, pkg of 20

Cuff starter kit, bladderless

Usage

Reusable

Reusable

Reusable

Reusable

Reusable

Reusable

Reusable

Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Reusable

Large adult

Adult thigh

Adult

Large adult

Neonate

Neonate

Neonate

Neonate

Child/Small adult/

Adult/Adult thigh

Applicable patient

Infant

Small Adult

Adult

Adult

Adult thigh

Adult

Adult

Child

Small adult

Adult

BeneVision N1 Patient Monitor Operator’s Manual 25 - 7

25.5

IBP Accessories

25.5.1

IBP Accessories Available for Purchase

Model

IM2202

IM2201

IM2204

/

Part No.

001C-30-70757

001C-30-70759

040-001029-00

125-000123-00

Description

12 Pin IBP cable, Argon

12 Pin IBP cable, ICU Medical

IBP extended cable with dualreceptacle

12 Pin IBP cable, Edwards (not for transportation)

Usage

Reusable

Reusable

Reusable

Reusable

Applicable patient

/

/

/

/

25.5.2

ICP Accessories Available for Purchase

Model

82-6653

CP12601

Part No.

040-002336-00

009-005460-00

Description

Codman ICP sensor kit, Johnson &

Johnson, pkg of 1

12-pin ICP cable

Usage

Disposable

Reusable

Applicable patient

/

/

25.6

CO

2

Accessories

25.6.1

Sidestream CO

2

Accessories Available for Purchase

Model

4000

4100

4200

60-15200-00

60-15300-00

60-14100-00

040-001187-00

040-001187-00

60-14200-00

100-000080-00

100-000081-00

Part No.

115-043001-00

115-043002-00

115-043003-00

115-043017-00

115-043018-00

115-043020-00

040-001187-00

115-043019-00

115-043021-00

115-058733-00

115-058734-00

Description

CO2 Nasal sample cannula, 7'’ line, pkg of 25

CO2 Nasal sample cannula, 7'’ line, pkg of 25

CO2 Nasal sample cannula, 7'’ line, pkg of 25

Sampling line, 2.5 m, pkg of 25

Sampling line, 2.5 m, pkg of 25

Dryline airway adapter, straight, pkg of 10

Airway Adapter

Airway Adapter pkg of 10

Dryline airway adapter, elbow pkg of 10

Watertrap, DRYLINE II, pkg of 10

Watertrap, DRYLINE II, pkg of 10

Usage

Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Reusable

Reusable

Applicable patient

Adult

Pediatric

Neonatal

Adult/Pediatric

Neonatal

Adu/Ped

Neonatal

Neonatal

/

Adult/Pediatric

Neonatal

25 - 8 BeneVision N1 Patient Monitor Operator’s Manual

25.6.2

Microstream CO

2

Accessories Intended for Sale

Model

/

Part No.

045-003134-00

Description

CO2 adapter

25.6.3

Microstream CO

2

Accessories Also Compatible

Model

009822

007269

009826

007743

008177

008178

008179

008180

XS04620

XS04624

006324

007768

007737

007738

009818

007266

008181

008174

008175

25.7

External Modules

Part No.

0010-10-42560

0010-10-42561

0010-10-42562

0010-10-42563

0010-10-42564

0010-10-42565

0010-10-42566

0010-10-42567

0010-10-42568

0010-10-42569

0010-10-42570

0010-10-42571

0010-10-42572

0010-10-42573

0010-10-42574

0010-10-42575

0010-10-42576

0010-10-42577

0010-10-42578

Description Usage

FilterLine Set Disposable

FilterLine H Set Disposable

FilterLine H Set

FilterLine Set, long

Disposable

Disposable

FilterLine H Set, long

FilterLine H Set, long

S CapnoLine Plus

Smart CapnoLine

Disposable

Disposable

Disposable

Disposable

S CapnoLine Plus O2

Smart CapnoLine O2

S CapnoLine Plus O2, long

S CapnoLine O2, long

CapnoLine H

CapnoLine H

CapnoLine H

CapnoLine H O2

CapnoLine H O2 Disposable

NIV-Line Disposable

NIV-Line Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Disposable

Part No.

115-053711-00

115-049134-00

6800-30-50820

Description

Sidestream CO2 module, with neonatal accessories

Sidestream CO2 module, with adult and pediatric accessories

Microstream CO2 module, with accessories

Usage

Reusable

Applicable patient

Pediatric

Adult

Pediatric

Adult

Pediatric

Neonate

Adult

Pediatric

Adult

Pediatric

Adult, pediatric

Neonate

Adult, pediatric

Adult, pediatric

Neonate

Adult

Pediatric

Adult

25.8

Mount and Mounting Accessories

Part No.

115-028320 -00

Description

Monitor handle

BeneVision N1 Patient Monitor Operator’s Manual 25 - 9

Part No.

115-048378-00

115-054849-00

115-054851-00

115-048990-00

045-001229-00

045-001230-00

045-002198-00

045-003427-00

045-001228-00

034-000454-00

034-000457-00

034-000456-00

045-000934-00

045-000924-00

115-050757-00

Description

Modular Rack kit

Dock and pole mount kit

Modular Rack and folding hook kit

Bedrail hook kit

LCD wall-mount bracket

Pole mounting kit

Dock wall mount bracket

GCX M series wall mount with quick release

N1/T1 docking station wall-mount (for LCD)

GCX M series arm, 16", with 6” riser

GCX M series 12” pivot arm

GCX VHM variable height arm

Keyboard wall-mount bracket

Rolling stand with quick release mount

Hook kit

25.9

Miscellaneous Accessories

Part No.

009-009766-00

009-006594-00

009-005123-00

009-006593-00

115-048379-00

115-048384-00

009-005391-00

023-001788-00

023-001566-00

115-048139-00

115-049427-00

DA8K-10-14452

115-048417-00

023-000524-00

023-000525-00

023-000247-00

023-000248-00

115-039575-00

115-039635-00

Description

N Series to N1/T1 docking station cable, 20 m

N Series to N1/T1 docking station cable, 10 m

N Series to N1/T1 docking station cable, 4 m

N Series to N1/T1 docking station cable, 2 m

Dock, with power cord

Transport Dock

MPM analog output and defib sync cable

External display, 21.5”

HP LaserJet Enterprise M608n, black and white

AC adapter kit

Lithium battery kit

Power cord

N1 Accessories Storage Box

Wireless keyboard and mouse set

Wired keyboard and mouse set

Keyboard, wired USB connector, black

Mouse, wired USB connector, black

2D Barcode reader, HS-1M, JADAK

2D Barcode reader, HS-1R, JADAK

25 - 10 BeneVision N1 Patient Monitor Operator’s Manual

Part No.

042-007382-00

Description

Cable management hook

BeneVision N1 Patient Monitor Operator’s Manual 25 - 11

This page intentionally left blank.

25 - 12 BeneVision N1 Patient Monitor Operator’s Manual

A

Product Specifications

A.1

A.2

A.3

Monitor Safety Specifications

The monitor is classified, according to IEC 60601-1: 2005:

Degree of protection against electrical shock

Type of protection against electrical shock

Degree of protection against harmful ingress of water

Type CF defibrillation proof for ECG, RESP, TEMP, IBP, SpO

2 , and NIBP

Type BF defibrillation proof for CO

2

Class I

Degree of safety of application in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide

Mode of operation

N1 monitor: IP44 (protected against ingress of foreign objects no less than 1.0 mm, and against access to hazardous parts with wire; protect against harmful effects of splashing water)

Dock/Modular Rack/AC Adapter: IPX1 (protected against harmful effects of vertically falling water drops)

Transport Dock: IP22 (protected against ingress of foreign objects no less than

12.5 mm and against access to hazardous parts with finger; protected against harmful effects of vertically falling water drops with the device tilted at any angle up to 15°)

The equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide

Continuous

Physical Specifications

Item

N1 main unit

N1 main unit

Modular Rack

Dock

Transport Dock

Transport Dock

Microstream CO

2 module

Sidestream CO

2

module

IBP module

Maximum

Weight (kg)

2.51

1.80

0.40

0.52

0.26

0.95

1.17

0.60

0.97

W × H × D (mm) Comments

148.5 × 103 × 81

148.5 × 103 × 81

165 ×130×168

190×125×155

162.4×253×195.5

162.4×113×195.5

136.5 × 40 × 102

136.5 × 40 × 102

136.5 × 40 × 102 without internal CO

2

module with internal CO

2

module

/

/ with cable box without cable box

/ without O

2

/

Environmental Specifications

WARNING

The monitor may not meet the performance specifications if stored or used outside the specified temperature and humidity ranges. If the performance of the equipment is degraded due to aging or environmental conditions, contact your service personnel.

The monitor cannot be transported in the temperature lower than -30ºC.

BeneVision N1 Patient Monitor Operator’s Manual A - 1

A.4

A.4.1

When the monitor and related products have differing environmental specifications, the effective range for the combined products is that range which is common to the specifications for all products.

NOTE

The environmental specification of unspecified parameter modules are the same as those of the main unit.

Components

Main Unit/

Transport Dock/

AC Adapter

Property (unit)

Temperature (°C)

Relative humidity

(noncondensing) (%)

Barometric (mmHg)

Operating Condition

0 to 40

5 to 95

Storage Condition

-30 to 70

5 to 95

Modular Rack/

Dock

Microstream CO

2 module

Sidestream CO

2 module

Temperature (°C)

Relative humidity

(noncondensing) (%)

Barometric (mmHg)

Temperature (°C)

Relative humidity

(noncondensing) (%)

Barometric (mmHg)

Temperature (°C)

Relative humidity

(noncondensing) (%)

Barometric (mmHg)

427.5 to 805.5

0 to 40

15 to 95

427.5 to 805.5

0 to 40

15 to 95

430 to 790

5 to 40

15 to 95

375 to 805.5 (with CO

2

)

120 to 805.5 (without CO

2

)

-20 to 60

10 to 95

120 to 805.5

-20 to 60

10 to 95

430 to 790

-20 to 60

10 to 95

430 to 790 375 to 805.5

Transient operating conditions

The monitor is operated in normal use for a period not less than 20 minutes when moved from room temperature ( 20 °C ± 2 °C) to an environment of a temperature range from - 20 °C to 50 °C, and relative humidity range from 15% to 95% (non-condensing).

The monitor is operated in normal use for a period not less than 20 minutes when moved from storage temperature (range from - 30 °C to 70 °C) to room temperature ( 20 °C ± 2 °C), and started up within 10 minutes after the movement.

Power Supply Specifications

External Power Supply Specifications

N1 main unit

Input voltage

Input current

AC Adapter

Input

Output

Dock

Input voltage

12VDC (±10%)

2 A

100 to 240 VAC (-15%, +10%), 50/60 Hz (±3 Hz), 1.0A to 0.6A

12VDC (±10%), 2.5A

100 to 240VAC (±10%)

A - 2 BeneVision N1 Patient Monitor Operator’s Manual

N1 main unit

Input voltage

Input current

Frequency

Transport Dock

Input

Output

A.4.2

Battery Specifications

Battery type

Voltage

Run time

A.5

12VDC (±10%)

0.65A to 0.35A

50/60Hz (±3Hz)

100 to 240 VAC (-15%, +10%), 50/60 Hz (±3 Hz), 1.0A to 0.6A

AC waveform: sine

12VDC (±10%), 2.5A

Charge time

Rechargeable lithium-Ion battery

7.2 VDC

At least 8 hours when the monitor without internal CO

2

module is powered by two new fully-charged batteries at 25°C ± 5°C with factory default screen brightness, Wi-Fi disabled, ECG and SpO

2

cable connected, and auto NIBP measurements at an interval of 15 minutes.

At least 3 hours when the monitor with internal CO

2

module is powered by one new fully-charged battery at 25°C ± 5°C with factory default screen brightness, Wi-Fi enabled, CO

2 sampling line connected, Temp, IBP, ECG and

SpO

2

cable connected, and auto NIBP measurements at an interval of 15 minutes.

Shutdown delay: at least 15 minutes after the low battery alarm first occurs.

For the monitor without internal CO

2

module: no more than 6 hours to 90% when the monitor is off.

no more than 10 hours to 90% when the monitor is on.

For the monitor with internal CO

2

module: no more than 3 hours to 90% when the monitor is off.

no more than 5 hours to 90% when the monitor is on.

Display Specifications

N1 main unit

Screen type

Screen Size (diagonal)

Resolution

Pixel per inch (PPI)

External display

Screen type

Screen Size (diagonal)

Resolution

Color TFT LCD

5.5 inches

1280 x 720 pixels

269

Medical-grade color TFT LCD

19 inches, 22 inches

1280 x 720 pixels

BeneVision N1 Patient Monitor Operator’s Manual A - 3

A.6

Touchscreen Specifications

Screen type Capacitive, multi-point touch

A.7

A.7.1

LEDs

Main Unit

Alarm lamp

Power-on LED

External power LED

Battery LED

1 (three color-coded: red, yellow, and cyan)

1 (green)

1 (green)

1 (two color-coded: yellow and green)

A.7.2

Dock

Connection status LED

External power supply LED

A.7.3

Transport Dock

Power-on LED

A.7.4

AC Adapter

Power-on LED

1 (green)

1 (green)

1 (green)

1 (green)

A.8

Audio Indicator

Speaker Give alarm tones (45 to 85 dB), reminder tones, key tones, QRS tones; support

PITCH TONE and multi-level tone modulation; alarm tones comply with IEC

60601-1-8:2012.

A.9

A.9.1

Monitor Interface Specifications

Interface Specifications of the Main Unit

DC power input connector

Multifunctional connector

Multi-pin connector

Communication interface

Infrared filter

Contact

Power switch

Sample line connector of the Sidestream

CO

2

1

1

1

2

1

4

1

1

A - 4 BeneVision N1 Patient Monitor Operator’s Manual

Gas outlet

ECG cable connector

SpO

2

sensor connector

NIBP cuff connector

IBP cable connector

Temperature probe connector

1

1

1

1

1

2

A.9.2

Interface Specifications of the Modular Rack

Multi-pin connector

Infrared filter

Pogo pin

Contact

3

2

2

1

A.9.3

Interface Specifications of the Dock

Network connector

Equipotential grounding terminal

AC power input connector

VGA connector

Host monitor connector

USB connector

Multi-pin connector

1

1

1

1

1

2

1

A.10

Signal Outputs Specifications

ECG Analog Output

Bandwidth

(-3dB; reference frequency: 10Hz)

Maximum QRS delay

Gain (reference frequency 10Hz)

Pace enhancement

Diagnostic mode: 0.05 to 150 Hz

Monitor mode: 0.5 to 40 Hz

Surgical mode: 1 to 20 Hz

ST mode: 0.05 to 40 Hz

25 ms (in diagnostic mode, and non-paced)

1V/mV (±5%)

Signal amplitude: V oh

≥2.5V

Pulse width: 10ms±5%

Signal rise and fall time: ≤100μs

IBP Analog Output

Bandwidth (-3dB; reference frequency:1Hz)

Maximum transmission delay

Gain (reference frequency 1 Hz)

Defib Sync Pulse

Output impedance

Maximum time delay

0 to 40 Hz

30 ms

1 V/100 mmHg, ±5%

≤100 Ω

35 ms (R-wave peak to leading edge of pulse)

BeneVision N1 Patient Monitor Operator’s Manual A - 5

Amplitude

Pulse width

Video Output

Video signals

Alarm output

Alarm delay time from the monitor to remote equipment

Alarm signal sound pressure level range

High level: 3.5 to 5 V, ±5%, providing a maximum of 10 mA output current;

Low level: < 0.5 V, receiving a maximum of 5 mA input current.

100 ms ±10%

VGA signal

The alarm delay time from the monitor to remote equipment is ≤2 seconds, measured at the monitor signal output connector.

45 dB(A) to 85 dB(A) within a range of one meter

A.11

Data Storage

Trends

Events

NIBP measurements

Interpretation of resting 12-lead ECG results

Full-disclosure waveforms

OxyCRG view

A minimum of 120 hours of trend data for trend interval as low as 1 minute.

1000 events

1000 sets

20 sets

48 hours at maximum. The specific storage time depends on the waveforms stored and the number of stored waveforms.

A maximum of 48 hours of oxyCRG events

A.12

Out-Of-Hospital Transport - Standards Compliance

■ Shock Tests according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN60068-2-27

(peak acceleration up to 100g).

Random Vibration according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN 60068-2-

64 (RMS acceleration 5g).

Sinusoidal Vibration according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN 60068-

2-6 (acceleration up to amplitude 2g).

Bump Test according to IEC/EN60068-2-29 (peak acceleration 15 g, 1000 bumps).

Free Fall Test according to EN 60068-2-32 (height 1.2 m).

EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances.

EN 13718-1:2008 Medical vehicles and their equipment-Air ambulances-Part 1: Requirements for medical devices used in air ambulances.

IEC 60601-1-12:2014 Medical electrical equipment -Part 1-12: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.

RTCA DO-160G Environmental Conditions and Test Procedures for Airborne Equipment.

◆ Section 7 Operational Shocks and Crash Safety

◆ Section 8 Vibration (Category S for fixed wing and Category U2 for rotary wing)

MIL-STD-810G Environmental engineering considerations and laboratory tests

◆ Method 514.6 Category 13 - Fixed Wing Propeller Aircraft

◆ Method 514.6 Category 14 Category 14 Helicopter, General, UH-60

◆ Method 514.6 Category 20 - Ground vehicles - ground mobile

◆ Method 514.6 Category 24 - Helicopter minimum integrity test

Radiated susceptibility 20 V/m according to IEC 80601-2-30: 2018 (NIBP), ISO80601-2-55: 2018 (CO

2

),

ISO80601-2-56: 2017 (TEMP), ISO 80601-2-61: 2017 (SpO

2

).

Extended radiated susceptibility tests

A - 6 BeneVision N1 Patient Monitor Operator’s Manual

◆ TETRA 400: 27V/m

◆ GMRS 460; FRS 460; GSM 800/900; TETRA 800; iDEN 820; CDMA 850; LTE Band 5; GSM 1800; CDMA

1900; GSM 1900; DECT; LTE Band 1, 3,4, 25; UMTS; Bluetooth; WLAN; 802.11 b/g/n; RFID 2450; LTE Band

7: 28V/m

◆ LTE Band 13, 17; WLAN 802.11 a/n: 9V/m

Magnetic Field emission according to MIL STD 461F, Chapter RE101: Radiated emissions, magnetic field,

30Hz to 100KHz. Limit class: Army.

Magnetic Field susceptibility : Radiated susceptibility, magnetic field, 50 and 60 Hz, 30 A/m.

A.13

Wi-Fi Specifications

A.13.1

Wi-Fi Technical Specifications (MSD45N)

Protocol

Modulation mode

Operating frequency

Channel spacing

Wireless data rate

Output power

Operating mode

Data security

IEEE 802.11a/b/g/n

DSSS and OFDM

IEEE 802.11b/g/n (at 2.4 GHz)

ETSI: 2.4 GHz to 2.483 GHz

FCC: 2.4 GHz to 2.483 GHz

MIC: 2.4 GHz to 2.495GHz

KC: 2.4 GHz to 2.483 GHz

IEEE 802.11a/n (at 5 GHz)

ETSI: 5.15 GHz to 5.35 GHz, 5.47 GHz to 5.725 GHz

FCC: 5.15 GHz to 5.35 GHz, 5.725 GHz to 5.85 GHz

MIC: 5.15GHz to 5.35 GHz

KC: 5.15 GHz to 5.35 GHz, 5.47 GHz to 5.725 GHz,

5.725 GHz to 5.85 GHz

Not support the DFS channels

IEEE 802.11b/g: 5 MHz

IEEE 802.11n (at 2.4 GHz): 5 MHz

IEEE802.11a: 20 MHz

IEEE802.11n (at 5 GHz): 20 MHz

IEEE 802.11b: 1 Mbps to 11 Mbps

IEEE 802.11g: 6 Mbps to 54 Mbps

IEEE 802.11n: 6.5 Mbps to 72.2 Mbps

IEEE 802.11a: 6 Mbps to 54 Mbps

<20 dBm (CE requirements, detection mode: RMS)

<30 dBm (FCC requirements, detection mode: peak power)

Infrastructure

Standards: WPA-PSK, WPA2-PSK, WPA-Enterprise, WPA2-Enterprise, WPA/WPA2 CCKM

EAP method: EAP-FAST, EAP-TLS, EAP-TTLS, PEAP-GTC, PEAP-MSCHAPv2, PEAP-TLS, LEAP

Encryption: AES

A.13.2

Wi-Fi Performance Specifications

WARNING

All network functions of data communication are designed to operate on a private network.

A.13.2.1

System Capacity

Number of the monitors supported by a single AP: ≤ 16

Testing conditions are as follows:

Each monitor can communicate with the CMS.

Two monitors are used to view other monitors.

Only one monitor can transmit history data.

The weakest strength of the AP signal where the monitor is located cannot be less than -65 dBm.

BeneVision N1 Patient Monitor Operator’s Manual A - 7

A.13.2.2

Resistance to Wireless Interference

The distance between the interfering devices and the monitor is greater than 20 cm. A Wi-Fi interference (no greater than -85 dBm) in the same channel and a Wi-Fi interference (no greater than -50 dBm) in an adjacentchannel are presented synchronously. The interfering devices include, but are not limited to, 2.4 GHz wireless devices, cellular mobile networks, microwave ovens, intercoms, cordless phones, and ESU equipment. The interfering devices do not include Wi-Fi devices.

The monitoring network must support the following requirements:

The total delay of data transmission from the monitor to the CMS: ≤ 2 seconds.

The delay for monitor-related settings configured at the CMS to be effective: ≤ 2 seconds.

The total delay of data transmission from one monitor to the other: ≤ 2 seconds.

The delay for the monitor to reset alarms of another to be effective: ≤ 2 seconds.

A.13.2.3

Wi-Fi Network Stability

The ratio of the communication data loss on the CMS from any monitor does not exceed 0.1% over a 24-hour period (12 of the 16 monitors connected to the network roam for 30 times).

Testing conditions are as follows:

Number of the monitors supported by a single AP: ≤ 16.

Each monitor can communicate with the CMS.

Two monitors are used to view other monitors.

Only one monitor can transmit history data.

The weakest strength of the AP signal where the monitor is located cannot be less than -65 dBm.

A.13.2.4

Line of Sight Distance

The line of sight distance between the monitor and the AP is no less than 50 meters.

A - 8 BeneVision N1 Patient Monitor Operator’s Manual

A.14

Measurement Specifications

The adjustable range of alarm limits is the same with the measurement range of signals unless otherwise specified.

A.14.1

ECG Specifications

ECG

Standards

Lead set

ECG standard

Display sensitivity

Sweep speed

Bandwidth (-3dB)

Common mode rejection ratio

Notch filter

Differential input impedance

Input signal range

Accuracy of signal reproduction

Electrode offset potential tolerance

Lead-off detection current

Input offset current

Defibrillation protection

Patient leakage current

Calibration signal

ESU protection

Meets the requirements of IEC 60601-2-27: 2011 and IEC 60601-2-25: 2011

3-lead: I, II, III

5-lead: I, II, III, aVR, aVL, aVF, V

6-lead: I, II, III, aVR, aVL, aVF, Va, Vb

12-lead: I, II, III, aVR, aVL, aVF, V1 to V6

AHA, IEC

1.25 mm/mV (×0.125), 2.5 mm/mV (×0.25), 5 mm/mV (×0.5), 10 mm/mV (×1),

20 mm/mV (×2), 40 mm/mV (×4), Auto, less than 5% error

6.25 mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s, less than 5% error

Diagnostic mode:

Monitor mode:

Surgery mode:

ST mode:

High frequency cut-off (for 12lead ECG analysis):

0.05 to 150 Hz

0.5 to 40 Hz

1 to 20 Hz

0.05 to 40 Hz

350 Hz (0.05 to 350 Hz), 150 Hz (0.05 to 150

Hz), 35 Hz (0.05 to 35 Hz), 20 Hz (0.05 to 20

Hz) selectable

Diagnostic mode, monitor mode, surgery mode, ST mode, High Freq Cut-off:

>90 dB (with notch filter off )

Monitor mode, surgery mode, ST mode: >105 dB (with notch filter on)

50/60 Hz

Monitor, surgical, and ST mode: notch filter turns on automatically

Diagnostic mode and High Freq Cut-off: notch filter is turned on/off manually

≥5 MΩ

±8 mV (peak-to-peak value)

Use A and D methods based on IEC 60601-2-25: 2011 to determine frequency response.

±500 mV

Measuring electrode: <0.1 μA

Drive electrode: <1 μA

≤0.1 μA, (drive lead≤1μA)

Withstands 5000V (360 J) charge without data loss or corruption

Baseline recovery time: <5 s

Polarization recovery time: <10 s

Defibrillation energy absorption: ≤10% (100 Ω load)

<10 uA

1mV (peak-to-peak value) ±5%

Cut mode: 300 W

Coagulate mode: 100 W

Recovery time: ≤10 s

In compliance with the requirements in clause 202.6.2.101 of IEC 60601-2-27:

2011

Pace Pulse

BeneVision N1 Patient Monitor Operator’s Manual A - 9

A - 10

Pace pulse markers

Pace pulse rejection

Pace pulses meeting the following conditions are labelled with a PACE marker:

Amplitude:

Width:

Rise time:

No overshoot

±2 mV to ±700 mV

0.1 ms to 2 ms

10 μs to 100 μs (< 10% of pulse width)

When tested in accordance with the IEC 60601-2-27: 2011: 201.12.1.101.13, the heart rate meter rejects all pulses meeting the following conditions.

Amplitude:

Width:

Rise time:

No overshoot

±2 mV to ±700 mV

0.1 ms to 2 ms

10 μs to 100 μs (< 10% of pulse width)

HR

Measurement range

Resolution

Accuracy

Sensitivity

Minimum QRS detection threshold

HR averaging method

Response to irregular rhythm

Response time to heart rate change

Time to alarm for tachycardia

Tall T-wave rejection capability

Neonate: 15 to 350 bpm

Pediatric: 15 to 350 bpm

Adult: 15 to 300 bpm

1 bpm

±1 bpm or ±1%, whichever is greater.

200 μV (lead II)

Adult and pediatric: 0.16 – 0.48 mV

Neonate: 0.12 – 0.40 mV

In compliance with the requirements in Clause 201.7.9.2.9.101 b) 3) of IEC

60601-2-27: 2011, the following method is used:

If the last 3 consecutive RR intervals are greater than 1200 ms, the 4 most recent RR intervals are averaged to compute the HR. Otherwise, heart rate is computed by subtracting the maximum and minimum ones from the most recent 12 RR intervals and then averaging the remaining 10 RR intervals.

The HR value displayed on the monitor screen is updated no more than one second.

In compliance with the requirements in Clause 201.7.9.2.9.101 b) 4) of IEC

60601-2-27: 2011, the heart rates for the specified test signals after 20 seconds of stabilization are:

Ventricular bigeminy (waveform A1): 80±1 bpm

Slow alternating ventricular bigeminy (waveform A2): 60±1 bpm

Rapid alternating ventricular bigeminy (waveform A3): 120±1 bpm

Bidirectional systoles (waveform A4): 90±2 bpm

Meets the requirements of IEC 60601-2-27: 2011: Clause 201.7.9.2.9.101 b) 5).

From 80 to 120 bpm: less than 11 s

From 80 to 40 bpm: less than 11 s

Meets the requirements in Clause 201.7.9.2.9.101 b) 6) of IEC 60601-2-27: 2011.

Waveform

B1h-range:

B1-range:

B1d-range:

B2h-range:

B2-range:

B2d-range:

<11 s

<11 s

<11 s

<11 s

<11 s

<11 s

When the test is performed based on Clause 201.12.1.101.17 of IEC 60601-2-27:

2011, the heart rate calculation is not affected for QRS of 1 mV amplitude and

100 ms duration, T-wave duration of 180 ms and amplitude lower than 1.2 mV, and QT interval of 350 ms.

BeneVision N1 Patient Monitor Operator’s Manual

Arrhythmia Analysis Classifications Asystole, V-Fib/V-Tach, V-Tach, Vent Brady, Extreme Tachy, Extreme Brady, Vent

Rhythm, PVCs/min, Pauses/min, Couplet, Bigeminy, Trigeminy, R on T, Run

PVCs, PVC, Tachy, Brady, Missed Beat, Pacer Not Pacing, Pacer Not Capture,

Multiform PVC, Nonsus V-Tach, Pause, Irr Rhythm, A-Fib

ST Segment Analysis

Measurement range

Accuracy

Resolution

QT/QTc Analysis

Measurement range

-2.0 mV to +2.0 mV RTI

-0.8 mV to +0.8 mV: ±0.02 mV or ±10%, whichever is greater

Beyond this range: not specified

0.01mV

Accuracy

Resolution

12-lead ECG Interpretation

Sampling rate

Amplitude quantisation

QT: 200 to 800 ms

QTc: 200 to800 ms

QT-HR: 15 bpm to 150 bpm for adult, 15 bpm to 180 bpm for pediatric and neonate

QT: ±30 ms

QT: 4 ms

QTc: 1 ms

1000 samples/s (waveform)

500 samples/s (ECG algorithm)

24 bits

Alarm limit

HR High

HR Low

ST High

ST Low

QTc High

ΔQTc High

A.14.2

Resp Specifications

Technique

Lead

Respiration excitation waveform

Minimum respiration impedance threshold

Baseline impedance range

Bandwidth

Range

HR≤40bpm: (low limit + 2 bpm) to 40 bpm

HR > 40 bpm: (low limit + 5 bpm) to 295 bpm (Adult/Pediatric)

(low limit + 5 bpm) to 300 bpm (Neonate)

HR≤40bpm: 16 bpm to (high limit - 2 bpm) (Adult/Pediatric)

15 bpm to (high limit - 2 bpm) (Neonate)

HR > 40 bpm: 40 bpm to (high limit - 5 bpm)

(low limit + 0.2 mV) to 2.0 mV (ST alarm mode: Absolute)

0 mV to 2.0 mV (ST alarm mode: Relative)

-2.0 mV to (high limit - 0.2 mV) (ST alarm mode: Absolute)

-2.0 mV to 0 mV (ST alarm mode: Relative)

200 ms to 800 ms

30 ms to 200 ms

Step

HR≤40bpm: 1 bpm

HR > 40 bpm: 5 bpm

0.05 mV

10 ms

Trans-thoracic impedance

Options are lead I, II, and Auto.

<300 μA RMS, 62.8 kHz (±10%)

0.3Ω

200 to 2500 Ω (using an ECG cable with 1kΩ resistance)

0.2 to 2.5 Hz (-3 dB)

BeneVision N1 Patient Monitor Operator’s Manual A - 11

Sweep speed

Respiration Rate

Measurement range

Resolution

Accuracy

Zero RR alarm delay

Alarm limit

RR High

RR Low

3mm/s, 6.25 mm/s, 12.5 mm/s, 25 mm/s or 50 mm/s, less than 10% error

Adult: 0 to 120 rpm

Pediatric, neonate: 0 to 150 rpm

1 rpm

7 to 150 rpm: ±2 rpm or ±2%, whichever is greater

0 to 6 rpm: not specified

10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s

Range (rpm)

Adult, pediatric:

RR≤20

RR>20

Neonate:

RR≤20

RR>20

RR≤20:

RR>20:

(low limit + 2) to 20

(low limit + 5) to 100

(low limit + 2) to 20

(low limit + 5) to 150

0 to (high limit - 2)

20 to (high limit - 5)

Step (rpm)

RR≤20: 1

RR>20: 5

A.14.3

SpO

2

Specifications

Refer to Appendix F SpO

2

Sensor Accuracy for the clinical study results of SpO

2

sensor accuracy.

Alarm limit

SpO

2

High

SpO

2

Low

SpO

2

Desat Low

Range (%) Step (%)

(low limit + 2) to 100

Masimo: (Desat+1) to (high limit - 2)

Nellcor: (Desat+1) or 20 (whichever is greater) to (high limit - 2)

0 to (SpO2 low limit - 1)

1

Masimo SpO

2

Module

Standards

Measurement range

Resolution

Response time

Accuracy

1

Refresh rate

SpO

2

averaging time

Low perfusion conditions

Low perfusion SpO

2

accuracy

2

PI measurement range

Meets the requirements of ISO 80601-2-61: 2017

1 to 100%

1%

≤20 s (normal perfusion, no disturbance, SpO2 value sudden change from 70% to 100%)

70 to 100%: ±2%ABS (adult/pediatric, without motion)

70 to 100%: ±3%ABS (adult/pediatric, with motion)

70 to 100%: ±3%ABS (neonate)

1% to 69%: Not specified.

≤ 1 s

2-4 s, 4-6 s, 8 s, 10 s, 12 s, 14 s, 16 s

Pulse amplitude: >0.02%

Light penetration: >5%

±2%

0.02 to 20%

A - 12 BeneVision N1 Patient Monitor Operator’s Manual

1

The Masimo pulse oximeter with sensors have been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses

68% of the population. One percent was added to the accuracies for neonatal sensors to account for accuracy variation due to properties of fetal hemoglobin.

The Masimo pulse oximeter with sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz. At an amplitude of 1 to

2 cm and non-repetitive motion between 1 to 5 Hz. At an amplitude of 2 to 3 cm in induced hypoxia studies in the range of

70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

2

The Masimo pulse oximeter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

Nellcor SpO

2

Module

Measurement range

Resolution

Refresh rate

Response time

0 to 100%

1%

≤1 s

≤30 s (normal perfusion, no disturbance, SpO

2

value sudden changes from

70% to 100%)

Accuracy 70 to 100%: ±2%ABS (adult/pediatric)

70 to 100%: ±3%ABS (neonate)

0 to 69%: Not specified.

When the SpO

2

sensor is applied for neonatal patients as indicated, the specified accuracy range is increased by ±1%, to compensate for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood.

A.14.4

PR Specifications

Alarm limit

PR High

PR Low

Range (bpm)

PR≤40: (low limit + 2) to 40

PR > 40: (low limit + 5) to 295 (Adult/Pediatric),

(low limit + 5) to 300 (Neonate)

PR≤40: 16 to (high limit - 2) (Adult/Pediatric),

15 to (high limit - 2) (Neonate)

PR > 40: 40 to (high limit - 5)

PR from Masimo SpO

2

Measurement range

Resolution

Response time

Accuracy

Step (bpm)

PR≤40: 1

PR>40: 5

25 to 240 bpm

1 bpm

≤20 s (with normal perfusion, no disturbance, and a PR value transition from

25 to 220 bpm)

±3 bpm (without motion)

±5 bpm (with motion)

≤1 s Refresh rate

PR from Nellcor SpO

2

Measurement range

Resolution

20 to 300 bpm

1 bpm

BeneVision N1 Patient Monitor Operator’s Manual A - 13

Response time

Accuracy

Refresh rate

PR from NIBP

Measurement range

Resolution

Accuracy

PR from IBP

Measurement range

Resolution

Accuracy

≤30 s (with normal perfusion, no disturbance, and a PR value transition from

25 to 250 bpm)

20 to 250 bpm: ±3 bpm

251 to 300 bpm: not specified

≤1 s

30 to 300 bpm

1 bpm

±3 bpm or ±3%, whichever is greater

25 to 350 bpm

1 bpm

±1 bpm or ±1%, whichever is greater

A.14.5

Temp Specifications

Standard

Technique

Operating mode

Measurement range

Resolution

Accuracy

Minimum time for accurate measurement

Alarm limit

Txx High (xx refers to temperature site)

Txx Low (xx refers to temperature site)

ΔT High

Meets the requirements of ISO 80601-2-56: 2017

Thermal resistance

Direct mode

0 to 50 °C (32 to 122 °F)

0.1°C

±0.1 °C or ±0.2 °F (excluding probe error)

Body surface: <100 s

Body cavity: <80 s

Range

(low limit +1.0) to 50.0 °C

(low limit +2.0) to 122.0 °F

0.1 to (high limit - 1.0) °C

32.2 to (high limit - 2.0) °F

0.1 to 50.0 °C

0.2 to 90.0 °F

Step

0.1 °C

0.1 °F

A.14.6

NIBP Specifications

Standard

Technique

Mode of operation

Auto mode repetition intervals

STAT mode cycle time

Max measurement time

Heart rate range

Meets the requirements of IEC 80601-2-30: 2018

Oscillometry

Manual, Auto, STAT, Sequence

1, 2, 2.5, 3, 5, 10, 15, 20, 30, 60, 90, 120, 180, 240 or 480 min

5 min

Adult, pediatric: 180 s

Neonate: 90 s

30 to 300 bpm

A - 14 BeneVision N1 Patient Monitor Operator’s Manual

Measurement ranges

(mmHg)

Accuracy

Resolution

Initial cuff inflation pressure range

(mmHg)

Default initial cuff inflation pressure

(mmHg)

Software overpressure protection

Static pressure measurement range

Static pressure measurement accuracy

Alarm limit

NIBP-S High

NIBP-S Low

NIBP-M High

NIBP-M Low

NIBP-D High

NIBP-D Low

Adult

25 to 290 Systolic:

Diastolic:

Mean:

Max mean error: ±5 mmHg

Max standard deviation: 8 mmHg

1mmHg

10 to 250

15 to 260

Adult: 80 to 280

Pediatric: 80 to 210

Neonate: 60 to 140

Adult: 160

Pediatric: 140

Neonate: 90

Adult: 297±3 mmHg

Pediatric: 297±3 mmHg

Neonate: 147±3 mmHg

0 mmHg to 300 mmHg

±3 mmHg

Range (mmHg)

Adult: (low limit + 5) to 285

Pediatric: (low limit + 5) to 235

Neonate: (low limit + 5) to 135

26 to (high limit - 5)

Adult: (low limit + 5) to 255

Pediatric: (low limit + 5) to 210

Neonate: (low limit + 5) to 120

16 to (high limit - 5)

Adult: (low limit + 5) to 245

Pediatric: (low limit + 5) to 195

Neonate: (low limit + 5) to 110

11 to (high limit - 5)

Pediatric

25 to 240

10 to 200

15 to 215

Step (mmHg)

NIBP ≤ 50: 1

NIBP > 50: 5

Neonate

25 to 140

10 to 115

15 to 125

BeneVision N1 Patient Monitor Operator’s Manual A - 15

NIBP-S Extreme High

NIBP-S Extreme Low

NIBP-M Extreme High

NIBP-M Extreme Low

NIBP-D Extreme High

NIBP-D Extreme Low

NIBP-S high limit < 50

Adult: (NIBP-S high limit + 1) to 290

Pediatric: (NIBP-S high limit + 1) to 240

Neonate: (NIBP-S high limit + 1) to 140

NIBP-S high limit ≥ 50

Adult: (NIBP-S high limit + 5) to 290

Pediatric: (NIBP-S high limit +5) to 240

Neonate: (NIBP-S high limit +5) to 140

NIBP-S low limit ≤ 50

25 to (NIBP-S low limit - 1)

NIBP-S low limit > 50

25 to (NIBP-S low limit - 5)

NIBP-M high limit < 50

Adult: (NIBP-M high limit + 1) to 260

Pediatric: (NIBP-M high limit + 1) to 215

Neonate: (NIBP-M high limit + 1) to 125

NIBP-M high limit ≥ 50

Adult: (NIBP-M high limit + 5) to 260

Pediatric: (NIBP-M high limit + 5) to 215

Neonate: (NIBP-M high limit + 5) to 125

NIBP-M low limit ≤ 50

15 to (NIBP-M low limit - 1)

NIBP-M low limit > 50

15 to (NIBP-M low limit - 5)

NIBP-D high limit < 50

Adult: (NIBP-D high limit + 1) to 250

Pediatric: (NIBP-D high limit + 1) to 200

Neonate: (NIBP-D high limit + 1) to 115

NIBP-D high limit ≥ 50

Adult: (NIBP-D high limit + 5) to 250

Pediatric: (NIBP-D high limit + 5) to 200

Neonate: (NIBP-D high limit + 5) to 115

NIBP-D low limit ≤ 50

10 to (NIBP-D low limit - 1)

NIBP ≤ 50: 1

NIBP > 50: 5

NIBP-D low limit > 50

10 to (NIBP-D low limit - 5)

*Measurement accuracy verification: In adult and pediatric modes, the blood pressure measurements measured with this device are in compliance with the Standard for Non-invasive sphygmomanometers (ISO 81060-2: 2013) in terms of mean error and standard deviation by comparing with intra-arterial or auscultatory measurements

(depending on the configuration) in a typical patient population. For auscultatory reference, the 5th Korotkoff sound was used to determine the diastolic pressure.

In neonatal mode, the blood pressure measurements measured with this device are in compliance with the

American National Standard for Non-invasive sphygmomanometers (ISO 81060-2) in terms of mean error and standard deviation by comparing with intra-arterial measurements (depending on the configuration) in a typical patient population.

A.14.7

IBP Specifications

Standard

Technique

Meets the requirements of IEC 60601-2-34: 2011

Direct invasive measurement

A - 16 BeneVision N1 Patient Monitor Operator’s Manual

IBP

Measurement range

Resolution

Accuracy

PPV

Measurement range

Pressure transducer

Excitement voltage

Sensitivity

Zero adjustment range

Impedance range

Volume displacement

Alarm limit

Sys High

Mean High

Dia High

Sys Low

Mean Low

Dia Low

Art-S Extreme High

Art-M Extreme High

Art-D Extreme High

Art-S Extreme Low

Art-M Extreme Low

Art-D Extreme Low

-50 to 300 mmHg

1 mmHg

±2% or ±1 mmHg, whichever is greater (excluding sensor error)

0% ~ 50%

5 VDC, ±2%

5 μV/V/mmHg

±200 mmHg

300 to 3000Ω

<0.04 mm

3

/100 mmHg

Range (mmHg)

IBP ≤ 50: (low limit + 2) to 50

IBP > 50: (low limit + 5) to 295

IBP ≤ 50: -49 to (high limit - 2)

IBP > 50: 50 to (high limit - 5)

High limit < 50: (High limit+ 1) to 300

High limit ≥ 50: (High limit+ 5) to 300 low limit ≤ 50: -50 to (low limit- 1) low limit > 50: -50 to (low limit- 5)

Step (mmHg)

IBP ≤ 50: 1

IBP > 50: 5

IBP ≤ 50: 1

IBP > 50: 5

A.14.8

CO

2

Specifications

Measurement mode

Technique

Zero RR delay

Alarm limit

Sidestream, microstream

Infrared absorption

10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s

Range

EtCO

2

High

EtCO

2

Low

FiCO

2

High

Sidestream CO

2

Module

(low limit + 2) to 99 mmHg

1 to (high limit - 2) mmHg

1 to 99 mmHg

Standard

CO

2

Measurement range

Meets the requirements of ISO 80601-2-55: 2018

0 to 150 mmHg

Step

1 mmHg

BeneVision N1 Patient Monitor Operator’s Manual A - 17

A - 18

CO

2

absolute accuracy* Full accuracy mode:

0 - 40 mmHg: ±2mmHg

41 - 76 mmHg: ±5% of reading

77 - 99 mmHg: ±10% of reading

100 - 150mmHg: ±(3mmHg + 8% of reading

ISO accuracy mode: Add ±2mmHg to the full accuracy mode

Accuracy specifications are affected by the breath rate and I:E. The EtCO

2

accuracy is within specification for breath rate ≤

60 rpm and I/E ratio ≤ 1:1, or breath rate ≤ 30 rpm and I/E ratio ≤ 2:1.

CO

2 resolution

Accuracy drift

Sample flowrate

1 mmHg

Meets the requirements for measurement accuracy within 6 hours

Using internal CO

2

module: 50 ml/min

Using the external CO

2

module

Adult, pediatric: 120 ml/min

Neonatal: 70 ml/min, 90 ml/min

Sample flowrate tolerance

Start-up time

Rise time

±15% or ±15 ml/min, whichever is greater.

Maximum: 90 s

Typically: 20 s

For CO

2 measurements (using external CO

2 moduler):

Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line:

≤250 ms@70 ml/min.

Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line:

≤250 ms@90 ml/min.

Measured with a DRYLINE II adult watertrap and a 2.5-meter adult sampling line:

≤300 ms@120 ml/min

For CO

2 measurements (using internal CO

2 module):

Measured with a standard Oridion sampling line:

≤250 ms@50 ml/min

Measured with a prolonged Oridion sampling line:

≤280 ms@50 ml/min

Response time awRR measurement range awRR measurement precision awRR resolution

Data sample rate

For CO

2 measurements (using external CO

2 module):

Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line:

≤5.0 s @ 70 ml/min

Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line:

≤4.5 s @ 90 ml/min

Measured with a DRYLINE II adult watertrap and a 2.5-meter adult sampling line:

≤5.0 s @ 120 ml/min

For CO

2 measurements (using internal CO

2 module):

Measured with a standard Oridion sampling line:

≤5.0 s@50 ml/min

Measured with a prolonged Oridion sampling line:

<6.5 s@50 ml/min

0 to 150 rpm

<60 rpm: ±1 rpm

60 to 150 rpm: ±2 rpm

1 rpm

50 Hz

BeneVision N1 Patient Monitor Operator’s Manual

Effect of interference gases on CO

2 measurements

Gas Concentration (%) Quantitative effect*

N

2

O

Hal

Sev

Iso

≤60

≤4

≤5

≤5

±1 mmHg

Enf

Des

≤5

≤15 ±2 mmHg

*: means an extra error should be added in case of gas interference when CO

2

measurements are performed between 0 to

40mmHg.

Microstream CO

2

Module

Standard

CO

2

Measurement range

Accuracy*

Meets the requirements of ISO 80601-2-55: 2018

0 to 99 mmHg

0 to 38 mmHg:

39 to 99 mmHg:

±2 mmHg

±5% of the reading (0.08% of the reading increased in error for every 1 mmHg if the reading is more than 38 mmHg)

Accuracy drift Meets the requirements for measurement accuracy within 6 hours

* Accuracy applies for respiration rate up to 80 rpm. For respiration rate above 80 rpm and EtCO

2

exceeding 18 mmHg, the accuracy is 4 mmHg or ±12% of the reading, whichever is greater. For respiration rate above 60 rpm, the above accuracy can be achieved by using the CapnoLine H Set for Infant/Neonatal. In the presence of interfering gases, the above accuracy is maintained to within 4%.

Resolution

Sample flow rate

1 mmHg

50 (- 7.5/+15) ml/min

Initialization time

Response time awRR measurement range awRR measurement accuracy awRR resolution

Data sample rate

Maximum 180 s

≤2.9 s

(The response time is the sum of the rise time and the delay time when using a FilterLine of standard length)

Rise time: <190ms@50%

Delay time: ≤2.7 s

0 to 150 rpm

0 to 70 rpm:

71 to 120 rpm:

121 to 150 rpm:

1 rpm

40 Hz

±1 rpm

±2 rpm

±3 rpm

BeneVision N1 Patient Monitor Operator’s Manual A - 19

This page intentionally left blank.

A - 20 BeneVision N1 Patient Monitor Operator’s Manual

B

EMC and Radio Regulatory Compliance

B.1

EMC

The device meets the requirements of IEC 60601-1-2: 2014.

WARNING

Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

The non-ME EQUIPMENT (e.g. information technology equipment (ITE)) that is a part of an ME

SYSTEM may be disrupted by the electromagnetic interference of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the non-ME EQUIPMENT or shielding the location.

Use of this equipment adjacent to, or stacked with, other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

This equipment is intended for use in professional healthcare facility EMC environment and home healthcare EMC environment. If it is used in a special environment, such as a magnetic resonance imaging environment, the equipment/system may be disrupted by the operation of nearby equipment.

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the this device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Guidance and Declaration - Electromagnetic Emissions

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Emission tests Compliance Electromagnetic environment - guidance

Conducted and radiated RF

EMISSIONS CISPR 11

Conducted and radiated RF

EMISSIONS

CISPR 11

Conducted and radiated RF

EMISSIONS

CISPR 11

Harmonic distortion

IEC 61000-3-2: 2014

Voltage fluctuations and flicker

IEC 61000-3-3: 2013

Group 1

Class B

Class A

(Used with Dock)

Class A

Complies

The device uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

The device is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

If the system is operated within the electromagnetic environment listed in Table Guidance and Declaration -

Electromagnetic Immunity, the system will remain safe and provide the following essential performance:

■ Operating mode

BeneVision N1 Patient Monitor Operator’s Manual B - 1

B - 2

Accuracy

Function

Accessories identification

Data stored

Alarm

Detect for connection

NOTE

If the essential performance is lost or degraded, it may be necessary to take mitigation measures, such as re-orienting or relocating the ME EQUIPMENT or ME SYSTEM or shielding the location.

During this time, the user should stop using the monitor and contact the service personnel.

The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below.

Other devices may interfere with this device even though they meet the requirements of CISPR.

When an input signal is below the minimum amplitude provided in technical specifications, erroneous measurements could result.

The EMISSIONS characteristics of this device make it suitable for use in industrial areas and hospitals

(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this device might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the device.

Guidance and Declaration - Electromagnetic Immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Immunity test IEC60601test level Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC

61000-4-2: 2008

Electrical fast transient/burst IEC

61000-4-4: 2012

Surge IEC 61000-4-5:

2014

Voltage dips and voltage interruptions

IEC 61000-4-11: 2004

±8 kV contact

±15 kV air

±2 kV for power supply lines

±1 kV for input/ output lines

(length greater than 3 m)

±1 kV line(s) to line(s)

±2 kV line(s) to earth

0 % U

T

for 0.5 cycle: at

0°, 45°, 90°, 135°, 180°,

225°, 270° and 315°

0 % U

T

for 1 cycle and

70 % U

T

for 25/30 cycles: at 0°

±8 kV contact

±15 kV air

±2 kV for power supply lines

±1 kV for input/ output lines

(length greater than 3 m)

±1 kV line(s) to line(s)

±2 kV line(s) to earth

0 % U

T

for 0.5 cycle: at

0°, 45°, 90°, 135°, 180°,

225°, 270° and 315°

0 % U

T

for 1 cycle and

70 % U

T

for 25/30 cycles: at 0°

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of our product requires continued operation during power mains interruptions, it is recommended that our product be powered from an uninterruptible power supply or a battery.

RATED power frequency magnetic fields

IEC 61000-4-8: 2009

0 % U

T

for 250/300 cycle

30 A/m

50 Hz/60 Hz

0 % U cycle

T

30 A/m

for 250/300

50 Hz/60 Hz

Note: U

T

is the AC mains voltage prior to application of the test level.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

BeneVision N1 Patient Monitor Operator’s Manual

Guidance and Declaration - Electromagnetic Immunity

The device is intended for use in the specified electromagnetic environment. The customer or the user of the device should assure that it is used in such an environment as described below.

Immunity test IEC60601 test level Compliance level

Conducted disturbances induced by RF fields

IEC61000-4-6: 2013

3 Vrms

150 kHz to 80 MHz

6 Vrms in ISM bands and amateur radio bands a between 0.15 MHz and 80 MHz

3Vrms

6 Vrms

Electromagnetic environment - guidance

Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter. Recommended separation distances: d = 1.2

P

Radiated RF EM fields

IEC61000-4-3

10 V/m

80 MHz to 2.7 GHz

20V/m

80 MHz to 2.5 GHz

(IEC80601-2-30: 2018,

ISO80601-2-55: 2018,

ISO80601-2-56: 2017,

ISO80601-2-61: 2017)

10 V/m

20V/m

Recommended separation distances:

80 MHz to 800 MHz: d = 1.2

P

800MHz - 2.7GHz: d = 2.3

P

Where, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters

(m) b

.

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a

should be less than the compliance level in each frequency range b

.

Interference may occur in the vicinity of equipment marked with the following symbol:

Proximity fields from

RF wireless communications equipment

IEC61000-4-3:

2006+A1:2007+A2:20

10

27 V/m

380 - 390 MHz

28 V/m

430 - 470 MHz,

800 - 960 MHz

1700 - 1900 MHz,

2400 - 2570 MHz

27 V/m

28 V/m

/

9 V/m

704 - 787 MHz,

5100 - 5800 MHz

9 V/m

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a

The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0,15 MHz and

80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.

b

: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.

If the measured field strength in the location in which the ME EQUIPMENT or ME SYSTEM is used exceeds the applicable

RF compliance level above, the ME EQUIPMENT or ME SYSTEM should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ME EQUIPMENT or

ME SYSTEM .

c

: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

BeneVision N1 Patient Monitor Operator’s Manual B - 3

WARNING

The device is configured with a wireless network connector to receive wireless signal. Other devices may interfere with this device even though they meet the requirements of CISPR.

B.2

Recommended separation distances between portable and mobile RF communications equipment and the device

The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.

Separation distance in meters (m) according to frequency of the transmitter

Rated maximum output power of transmitter (W)

150 kHz to 80 MHz d = 1.2

P

80 MHz to 800 MHz d = 1.2

P

800 MHz to 2.7 GHz d = 2.3

P

0.01

0.1

1

10

0.12

0.38

1.20

3.80

0.12

0.23

0.38 0.73

1.20 2.30

3.80

7.30

100 12.00

12.00 23.00

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres

(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Radio Regulatory Compliance

This device complies with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Any changes or modifications to this equipment not expressly approved by Mindray may cause harmful radio frequency interference and void your authority to operate this equipment.

The maximum antenna gain permitted complies with the e.i.r.p. limits as stated in RSS-210.

The maximum antenna gain permitted complies with the e.i.r.p. limits specified for point-to-point operation, as stated in RSS-210.

WARNING

Changes or modifications not expressly approved by the party responsible compliance could void the user’s authority to operate the equipment.

B - 4 BeneVision N1 Patient Monitor Operator’s Manual

C

Default Settings

C.1

C.1.1

ECG, Arrhythmia, ST and QT Default Settings

ECG Default Settings

Item

HR Alarm switch

High limit

Priority

Alarm Outputs

Alarm Source

ECG1

ECG2 (5-lead, 6-lead, 12-lead)

Va (for 6-lead only)

Vb(for 6-lead only)

ECG Gain

Speed

Filter

Notch Filter

Lead Set

Smart Lead

QRS Volume

Baseline Drift Removal (for 12-lead only)

Waveform Layout (for 12-lead only)

QRS Threshold

Paced

Pacer Reject

Low limit

Default Setting

On

Adult: 120 bpm

Pediatric: 160 bpm

Neonate: 200 bpm

Adult: 50 bpm

Pediatric: 75 bpm

Neonate: 100 bpm

Med

Off

Auto

II

V (for 5-lead).Va (for 6-lead), V1 (for 12-lead)

Va

Vb

×1

25 mm/sec

OR: Surgery

CCU: Diagnostic

Other departments: Monitor

On

Auto

On

General and OR: 2

Other departments: 0

On

Standard

0.16 mV

Adult: Unspecified

Pediatric/neonate: No

Off

BeneVision N1 Patient Monitor Operator’s Manual C - 1

C.1.2

Arrhythmia Default Settings

C.1.2.1

Arrhythmia Alarm Default Settings

Item Alarm Switch

Asystole

V-Fib/V-Tach

V-Tach

Vent Brady

Extreme Tachy

Extreme Brady

R on T

Run PVCs

Couplet

Multiform PVC

PVC

Bigeminy

Trigeminy

Tachy

Brady

Pacer Not Capture

Pacer Not Pacing

Missed Beat

Nonsus V-Tach

Vent Rhythm

Pause

Irr Rhythm

A-Fib

PVCs/min

Pauses/min

On

On

On

On

On

On

CCU: On

Other departments: Off

Off

Off

Off

Off

CCU: On

Other departments: Off

CCU: On

Other departments: Off

Off

Off

Off

Off

Off

CCU: On

Other departments: Off

CCU: On

Other departments: Off

Off

Off

Off

CCU: On

Other departments: Off

CCU: On

Other departments: Off

Med

Low

Prompt

Prompt

Med

Med

Low

Prompt

Med

Prompt

Med

Med

Med

Med

Prompt

Prompt

Prompt

Med

Priority

High, unadjustable

High, unadjustable

High, unadjustable

High, unadjustable

High, unadjustable

High, unadjustable

Med

Off

Off

Off

Off

Off

Off

Off

Off

Off

Off

Off

Off

Off

Off

Off

Off

Off

Off

Alarm Outputs

Off

Off

Off

Off

Off

Off

Off

C - 2 BeneVision N1 Patient Monitor Operator’s Manual

C.1.2.2

Arrhythmia Threshold Default Settings

Item Default Setting

Asystole Delay

Tachy

Brady

Extreme Tachy

Extreme Brady

Multif PVCs Window

PVCs/min

Pauses/min

Pause Threshold

AF/Irr Rhy End Time

V-Tach Rate

V-Brady Rate

V-Tach PVCs

V-Brady PVCs

Adult

5 sec

120 bpm

50 bpm

160 bpm

35 bpm

15 beats

10

8

6

5

2.0 sec

2 min

130 bpm

40 bpm

C.1.3

ST Default Settings

Item

ST Alarm Mode

ST Alarm Mode set to Absolute :

ST-I, ST-II, ST-III, ST-aVR, ST-aVL, ST-aVF, ST-V1, ST-

V2, ST-V3, ST-V4, ST-V5,ST-V6, ST-Va, ST-Vb

ST Alarm Mode set to

ST Single,

ST Dual

Relative :

Alarm switch

High limit

Low limit

Priority

Alarm Outputs

Alarm switch

High limit

Low limit

Priority

Alarm Outputs

ST Analysis

ST Segment

Show Marker

ST Point

Auto Adjust

J

ISO

Default Setting

Auto

Off

J+60

On

-0.1 mV

Med

Off

Off

48

-80

Absolute

Off

0.2 mV

-0.2 mV

Med

Off

Off

0.1 mV

Pediatric

5 sec

160 bpm

75 bpm

180 bpm

50 bpm

15 beats

10

8

6

5

2.0 sec

2 min

130 bpm

40 bpm

BeneVision N1 Patient Monitor Operator’s Manual C - 3

C.1.4

C.1.5

QT Default Settings

Item

QTc

ΔQTc

QT Analysis

QT Lead

Alarm switch

High limit

Priority

Alarm Outputs

Alarm switch

High limit

Priority

Alarm Outputs

Default Setting

Med

Off

Off

All

Off

Adult: 500

Pediatric: 480

Neonate: 460

Med

Off

Off

60

Glasgow 12-lead ECG Algorithm Default Settings

Item

High Freq Cut-off

Baseline Drift Removal

Tachy

Brady

Waveform Layout

Median Complex

Measurements

Interpretation

Interpretation Summary

Default Setting

35 Hz

On

On

On

On

100

50

Standard

Off

C.2

Respiration Default Settings

Item

RR

Zero RR

Alarm switch

High limit

Low limit

Priority

Alarm Outputs

Alarm switch

Priority

Alarm Outputs

Default Setting

On

Adult: 30

Pediatric: 30

Neonate: 100

Adult: 8

Pediatric: 8

Neonate: 30

Med

Off

On

High, unadjustable

Off

C - 4 BeneVision N1 Patient Monitor Operator’s Manual

Item

Zero RR Delay

RR Source

Resp Lead

C.3

Gain

Speed

Auto Threshold Detection

SpO

2

Default Settings

Item

SpO

2

High limit

Low limit

Priority

Alarm Outputs

Alarm switch SpO

2

Desat

Low limit

Priority

Alarm Outputs

Satsecond (for Nellcor SpO

2

)

NIBP Simul

FastSAT (for Masimo SpO

2

)

Display SIQ (for Nellcor SpO

2

)

Display PI (for Masimo SpO

2

)

Speed

Default Setting

Adult: 20 sec

Pediatric: 20 sec

Neonate: 15 sec

Auto

Adult: Auto

Pediatric: Auto

Neonate: II

×2

6.25 mm/s

On

Default Setting

80%

High

Off

Off

Off

Off

Off

On

25 mm/s

On

Adult: 100%

Pediatric: 100%

Neonate: 95%

90%

Med

Off

On

BeneVision N1 Patient Monitor Operator’s Manual C - 5

C.4

C.5

Item

PR Alarm switch

High limit

Low limit

Priority

Alarm Outputs

Alarm Source

PR Source

Display PR

QRS Volume

Default Setting

On

Adult: 120

Pediatric: 160

Neonate: 200

Adult: 50

Pediatric: 75

Neonate: 100

Med

Off

Auto

Auto

On

General, OR: 2

Other departments: 0

Temperature Default Settings

Item

Txx

(xx refers to temperature site)

Alarm switch

High limit

Low limit

Priority

Alarm Outputs

High limit

Priority

Alarm Outputs

NIBP Default Settings

Item

Default Setting

On

38.0 °C

35.0 °C

Med

Off

On

2.0 °C

Med

Off

High limit

Low limit

Priority

Alarm Outputs

Default Setting

On

Adult: 160 mmHg

Pediatric: 120 mmHg

Neonate: 90 mmHg

Adult: 90 mmHg

Pediatric: 70 mmHg

Neonate: 40 mmHg

Med

Off

C - 6 BeneVision N1 Patient Monitor Operator’s Manual

Item

NIBP-M

High limit

Low limit

Priority

Alarm Outputs

Alarm switch

High limit

Low limit

NIBP-S Extreme

Priority

Alarm Outputs

Alarm switch

High limit

Low limit

NIBP-D Extreme

Priority

Alarm Outputs

Alarm switch

High limit

Low limit

NIBP-M Extreme

Priority

Alarm Outputs

Alarm switch

High limit

Low limit

Priority

Alarm Outputs

Default Setting

Adult: 75 mmHg

Pediatric: 60 mmHg

Neonate: 35 mmHg

High

Off

Off

Adult: 105 mmHg

Pediatric: 80 mmHg

Neonate: 65 mmHg

Adult: 35 mmHg

Pediatric: 30 mmHg

Neonate: 15 mmHg

High

Off

Off

Adult: 125 mmHg

Pediatric: 100 mmHg

Neonate: 75 mmHg

Adult: 45 mmHg

Pediatric: 40 mmHg

Neonate: 20 mmHg

High

Off

On

Adult: 90 mmHg

Pediatric: 70 mmHg

Neonate: 60 mmHg

Adult: 50 mmHg

Pediatric: 40 mmHg

Neonate: 20 mmHg

Med

Off

On

Adult: 110 mmHg

Pediatric: 90 mmHg

Neonate: 70 mmHg

Adult: 60 mmHg

Pediatric: 50 mmHg

Neonate: 25 mmHg

Med

Off

Off

Adult: 175 mmHg

Pediatric: 130 mmHg

Neonate: 95 mmHg

BeneVision N1 Patient Monitor Operator’s Manual C - 7

Item

Initial Pressure

Interval

C.6

Start Mode

NIBP End Tone

Venipuncture Pressure

Display Format

Display Alarm Limits

Display PR

IBP Default Settings

Item

IBP-S Alarm switch

High limit

Default Setting

Adult: 160 mmHg

Pediatric: 140 mmHg

Neonate: 90 mmHg

OR: 5 min

Neonatology: 30 min

Other departments: 15 min

Clock

Off

Auto

Sys/Dia (Mean)

Off

Off

Low limit

Priority

Alarm Outputs

Default Setting

On

■ Art/Ao/UAP/BAP/FAP/LV/P1-P2 arterial pressure

Adult: 160 mmHg

Pediatric: 120 mmHg

Neonate: 90 mmHg

■ PA

Adult: 35 mmHg

Pediatric and neonate: 60 mmHg

■ Art/Ao/UAP/BAP/FAP/LV/P1-P2 arterial pressure

Adult: 90 mmHg

Pediatric: 70 mmHg

Neonate: 55 mmHg

■ PA

Adult: 10 mmHg

Pediatric and neonate: 24 mmHg

Med

Off

C - 8 BeneVision N1 Patient Monitor Operator’s Manual

Item

IBP-D

IBP-M

Alarm switch

High limit

Low limit

Priority

Alarm Outputs

Alarm switch

High limit

Low limit

Priority

Alarm Outputs

Default Setting

On

■ Art/Ao/UAP/BAP/FAP/LV/P1-P2 arterial pressure

Adult: 90 mmHg

Pediatric: 70 mmHg

Neonate: 60 mmHg

■ PA

Adult: 16 mmHg

Pediatric and neonate: 4 mmHg

■ Art/Ao/UAP/BAP/FAP/LV/P1-P2 arterial pressure

Adult: 50 mmHg

Pediatric: 40 mmHg

Neonate: 20 mmHg

■ PA

Adult: 0 mmHg

Pediatric and neonate: -4 mmHg

Med

Off

On

■ Art/pArt/Ao/UAP/BAP/FAP/LV/P1-P2 arterial pressure

Adult: 110 mmHg

Pediatric: 90 mmHg

Neonate: 70 mmHg

■ PA

Adult: 20 mmHg

Pediatric and neonate: 26 mmHg

■ CVP

Adult: 14 cmH

2

O

Pediatric and neonate: 5 cmH

2

O

■ ICP/RAP/LAP/UVP/P3-P4 venous pressure

Adult: 10 mmHg

Pediatric and neonate: 4 mmHg

■ Art/Ao/UAP/BAP/FAP/LV/P1-P2 arterial pressure

Adult: 70 mmHg

Pediatric: 50 mmHg

Neonate: 35 mmHg

■ PA

Adult: 0 mmHg

Pediatric and neonate: 12 mmHg

■ CVP

Adult: 0 cmH

2

O

Pediatric and neonate: 0 cmH

2

O

■ ICP/RAP/LAP/UVP/P3-P4 venous pressure

Adult: 0 mmHg

Pediatric and neonate: 0 mmHg

Med

Off

BeneVision N1 Patient Monitor Operator’s Manual C - 9

C - 10

Item

Art-S Extreme Alarm switch

High limit

Low limit

Art-D Extreme

Priority

Alarm Outputs

Alarm switch

High limit

Low limit

Art-M Extreme

Priority

Alarm Outputs

Alarm switch

High limit

CPP

Low limit

Priority

Alarm Outputs

Alarm switch

High limit

Low limit

Measure (for P1, P2)

Measure (for P3, P4)

Sensitivity

Speed

Priority

Alarm Outputs

Default Setting

Adult: 55 mmHg

Pediatric: 40 mmHg

Neonate: 30 mmHg

High

Off

On

Adult: 130 mmHg

Pediatric: 100 mmHg

Neonate: 90 mmHg

Adult: 50 mmHg

Pediatric: 40 mmHg

Neonate: 30 mmHg

Med

Off

All

Mean Only

Med

25 mm/sec

Off

Adult: 175 mmHg

Pediatric: 130 mmHg

Neonate: 95 mmHg

Adult: 75 mmHg

Pediatric: 60 mmHg

Neonate: 50 mmHg

High

Off

Off

Adult: 105 mmHg

Pediatric: 80 mmHg

Neonate: 65 mmHg

Adult: 35mmHg

Pediatric: 30 mmHg

Neonate: 15 mmHg

High

Off

Off

Adult: 125 mmHg

Pediatric: 100 mmHg

Neonate: 75 mmHg

BeneVision N1 Patient Monitor Operator’s Manual

Item

Scale

Default Setting

0- 20 mmHg ICP/RAP/LAP/UVP venous pressure

Art/Ao/BAP/FAP/LV/P1/

P2 arterial pressure

UAP/P3/P4 venous pressure

CVP/PA

0-160 mmHg

0-80 mmHg

CVP: 0-30 cmH2O

PA: 0 - 30 mmHg

Sys/Dia (Mean)

Off

Off

Display Format

Display Alarm Limits

Use PA-D as PAWP (only available for independent external display)

PPV Measure

PPV Source

PAWP Reference Waveform 1

Reference Waveform 2

Speed

PA Scale

Overlapping

Waveform Setup

Left Scale

Right Scale

CVP Scale

ICP Scale

PA Scale

Speed

Gridlines

Off

Auto

II

Resp

12.5 mm/sec

0-30 mmHg

0-160 mmHg

0-20 mmHg

0-30 cmH2O

0-20 mmHg

0-30 mmHg

25 mm/sec

Off

C.7

C.7.1

CO

2

Default Settings

General Settings

Item

EtCO

2

Alarm

High limit

Low limit

Priority

Alarm Outputs

Default Setting

On

Adult and pediatric: 50 mmHg

Neonate: 45 mmHg

Adult and pediatric: 25mmHg

Neonate: 30mmHg

Med

Off

BeneVision N1 Patient Monitor Operator’s Manual C - 11

Item

FiCO

2

Zero RR Delay

RR Source

Speed

Scale

Waveform Type

High limit

Priority

Alarm Outputs

Default Setting

On

4 mmHg

Med

Off

Adult and pediatric: 20 s

Neonate: 15 s

Auto

6.25 mm/s

50 mmHg

Draw

C.7.2

Sidestream CO

2

Default Settings

Item

EtO

2

FiO

2

High limit

Low limit

Priority

Alarm Outputs

High limit

Low limit

Priority

Alarm Outputs

BTPS Compensation

O

2

Compensation (for CO

2

module without

O

2

measurement)

N

2

O Compenation

AG Compenation

Auto Standby

Operating Mode

Default Setting

On

88%

18%

Med

Off

On

Adult and pediatric: 100%

Neonate: 90%

18%

Med

Off

Off

OR: 100%

Other departments: 21%

0%

0%

60 min

Measure

C.7.3

Microstream CO

2

Default Settings

Item

BTPS Compen

Maximum Hold

Auto Standby

Operating Mode

Default Setting

Off

20 sec

Off

Measure

C - 12 BeneVision N1 Patient Monitor Operator’s Manual

C.8

C.9

Alarm Default Settings

Item

Alarm Volume

High Alarm Volume

Reminder Volume

Zero RR Delay

Printing Duration on Alarm

Auto Limits for New Patient

Default Setting

2

Alarm Volume + 2

2

Adult/Pediatric: 20 sec

Neonate: 15 sec

20 sec

On

Display Default Settings

Item

Choose Screen

Display

Night Mode

Brightness

Key Volume

Brightness

Alarm Volume

QRS Volume

Key Volume

NIBP End Tone

Stop NIBP

Default Setting

2

1

0

Off

Off

2

1

Normal Screen

5

BeneVision N1 Patient Monitor Operator’s Manual C - 13

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C - 14 BeneVision N1 Patient Monitor Operator’s Manual

D

Alarm Messages

D.1

D.1.1

This chapter lists only the physiological and technical alarm messages. Some messages appearing on your monitor may not be included. In the “Cause and solution” column, corresponding solutions are given instructing you to troubleshoot problems. If the problem persists, contact your service personnel.

Physiological Alarm Messages

General Physiological Alarm Messages

D.1.2

Alarm messages

XX High

XX Low

Default priority

Med

Med

Cause and solution

XX value has risen above the high alarm limit or fallen below the low alarm limit. Check the patient’s condition and check if the patient category and alarm limit settings are correct.

Note: XX represents a measurement or parameter label, such as HR, NIBP, PVCs, RR, SpO

2

, PR, etc.

Arrhythmia Alarm Messages

Alarm message

Asystole

V-Fib/V-Tach

V-Tach

Vent Brady

Extreme Tachy

Extreme Brady

R on T

Run PVCs

Couplet

Multiform PVC

PVC

Bigeminy

Trigeminy

Tachy

Brady

Pacer Not Pacing

Pacer Not Capture

Missed Beats

Nonsus. Vtac

Vent Rhythm

Pause

Default priority

Prompt

Med

Prompt

Med

Med

Med

Med

Prompt

High

High

Med

Low

High

High

High

High

Prompt

Prompt

Med

Med

Low

BeneVision N1 Patient Monitor Operator’s Manual D - 1

D.1.3

Alarm message

Irr Rhythm

PVCs/min

Pauses/min

A-Fib

Default priority

Prompt

Med

Med

Prompt

Note: When arrhythmia alarms occur, check the patient’s condition and the ECG connections.

Resp Physiological Alarm Messages

Alarm message

Resp Artifact

Zero RR

Default priority

High

High

Cause and solution

The patient’s heartbeat has interfered with the impedance respiration measurement. Check the patient’s condition and the ECG connections.

The respiration signal is so weak that the monitor cannot perform respiration analysis. Check the patient’s condition, module and patient connections.

D.1.4

SpO

2

Physiological Alarm Messages

Alarm message

SpO2 Desat

Default priority

High

Cause and solution

The SpO

2

value falls below the desaturation alarm limit. Check the patient’s condition and check if the alarm limit settings are correct.

D.1.5

PR Physiological Alarm Messages

Alarm message

No Pulse

Default priority

High

Cause and solution

The pulse signal is so weak that the monitor cannot perform pulse analysis. Check the patient’s condition and the source of the PR, such as

IBP or SpO2 sensor, and measurement site.

D.1.6 NIBP Physiological Alarm Messages

Alarm message

NIBP-S Extremely

High/NIBP-D

Extremely High/NIBP-

M Extremely High

NIBP-S Extremely

High/NIBP-D

Extremely High/NIBP-

M Extremely Low

Default priority

High

High

Cause and solution

The NIBP value is higher than the NIBP Extreme alarm high limit. Check the patient’s condition and check if the alarm limit settings are correct.

The NIBP value is lower than the NIBP Extreme alarm low limit. Check the patient’s condition and check if the alarm limit settings are correct.

D.1.7 IBP Physiological Alarm Messages

Alarm message

Art-S/Art-D/Art-M

Extremely High

Default priority Cause and solution

High The Art value is higher than the Art Extreme alarm high limit. Check the patient’s condition and check if the alarm limit settings are correct.

D - 2 BeneVision N1 Patient Monitor Operator’s Manual

Alarm message

Art-S/Art-D/Art-M

Extremely Low

Default priority Cause and solution

High The Art value is lower than the Art Extreme alarm low limit. Check the patient’s condition and check if the alarm limit settings are correct.

D.1.8

CO

2

Physiological Alarm Messages

D.2

Alarm message

FiO2 Shortage

Default priority

High

Cause and solution

FiO

2

concentration is less than 18%. Check the patient’s condition, the ventilated O

2

content and the airway connection.

Technical Alarm Messages

This section lists technical alarms, their default priority, responses on alarm reset, and the actions that can be taken when an alarm occurs. Some of alarms may not be included.

Various technical alarms respond differently when the alarm system is reset. For easy clarification, in this section the technical alarms are classified into three categories of response when the alarm system is reset:

A: technical alarms are cleared. The monitor gives no alarm indications.

B: technical alarms are changed to the prompt messages.

C: the alarm is silenced and a √ appears before the alarm message.

In the following tables A, B, and C are used to refer to the responses on alarm reset.

D.2.1

General Technical Alarm Messages

D.2.2

Alarm message Default priority

Indication on alarm reset

C

Cause and solution

XX Module Error High XX module does not work properly. Reinsert the module, if the alarm persists, contact your service personnel.

Note: XX represents a measurement or parameter label, such as HR, RR, SpO2, or EtCO2, etc.

ECG Technical Alarm Messages

Alarm message

ECG Noisy

ECG Amplitude Too Small

ECG (XX) Lead Off

ECG Signal Invalid

ECG Learning

Default priority

Low/Prompt

Indication on alarm reset

A

Low

Low

Low

Prompt

C

B

A

/

Cause and solution

The ECG signal is noisy. Check for any possible sources of signal noise around the cable and electrode, and check the patient for excessive motion.

The ECG amplitude does not reach the detected threshold. Check for any possible source of interference around the cable and electrode.

The electrode has become detached from the patient or the lead wire has become disconnected from the adapter cable. Check the connections of the electrodes and leadwires.

Patient skin impedance is too high. Check ECG electrode application.

ECG learning is manually or automatically triggered.

BeneVision N1 Patient Monitor Operator’s Manual D - 3

D.2.3

Alarm message Default priority

Indication on alarm reset

/

Cause and solution

Cannot Analyze QT Prompt /

Note: XX represents ECG lead name, for example RL, LL, V, Va, Vb, etc.

Resp Technical Alarm Messages

Alarm message

Resp Interference

Electrode Poor Contact

Default priority

Prompt

Indication on alarm reset

/

Prompt /

Cause and solution

The respiration circuit is disturbed. Check for any possible sources of signal noise.

Check the electrode application. Reposition or replace the electrodes if necessary.

D.2.4

SpO

2

Technical Alarm Messages

Alarm message

SpO2 Sensor Off Sensor

Off

Default priority

Low

Indication on alarm reset

B

SpO2 No Sensor No

Sensor

SpO2 Excess Light

SpO2 No Pulse

SpO2 Sensor

Incompatible

SpO2 Low Signal Quality

SpO2 Interference

SpO2 Sensor Error

SpO2 Searching Pulse

SpO2 Low Perfusion

Low

Low

Low

Low

Low

Low

Low

Prompt

Prompt

A

C

C

C

C

C

C

/

/

Cause and solution

The SpO

2

sensor has become detached from the patient or the module. Check the sensor connection. If the alarm persists, replace the sensor.

The SpO

2

extension cable is detached from the

SpO

2

module, or the SpO

2

sensor is detached from the SpO

2

extension cable. Check the SpO cable and the sensor connection. If the alarm

2 persists, replace the sensor.

Ambient light is too strong. Move the sensor to a place with lower level of ambient light or cover the sensor to minimize the ambient light.

The SpO

2

sensor failed to obtain pulse signal.

Check the patient’s condition and replace the sensor application site. If the alarm persists, replace the sensor.

Incompatible or an unspecified SpO

2

sensor is used. Use specified sensors.

1. Check the sensor and sensor position.

2. Make sure the patient is not shivering or moving.

3. The patient’s pulse may be too low to be measured.

The SpO

2

signal has interference. Check for any possible sources of signal noise and check the patient for excessive motion.

Replace the sensor and measure again.

SpO

2

is searching for pulse.

The SpO

2

sensor is not properly placed or the patient’s perfusion index is too low.

1. Check the sensor and sensor position.

2. Reposition the sensor if necessary.

D - 4 BeneVision N1 Patient Monitor Operator’s Manual

D.2.5

Temp Technical Alarm Messages

Alarm message

T1/T2 Sensor Off

Default priority

Low

Indication on alarm reset

A

Cause and solution

Check the sensor connection and reconnect the sensor.

D.2.6

NIBP Technical Alarm Messages

Alarm message

NIBP Loose Cuff

NIBP Air Leak

NIBP Airway Error

NIBP Weak Signal

NIBP Overrange

NIBP Excessive Motion

NIBP Cuff Overpress

NIBP Timeout

NIBP Cuff and Patient

Mismatch

NIBP Airway Leak

Default priority

Low

Indication on alarm reset

A

Low

Low

Low

Low

Low

Low

Low

Low

Low

A

A

A

A

A

A

A

A

A

Cause and solution

There is a leak in the cuff or air tubing. Use a cuff of correct type based on the patient size. Apply the cuff and connect the air tubing as instructed in the manual.

Check the NIBP cuff and pump for leakages.

The air tubing may be occluded. Check the air tubing for an occlusion or kinking. If the alarm persists, contact your service personnel.

The patient’s pulse is weak or the cuff is loose.

Check the patient’s condition and replace the cuff application site.

The measured NIBP value exceeds the module measurement range. Check the patient’s condition.

Check the patient’s condition and reduce patient motion.

The NIBP airway may be occluded. Check the airway and measure again. If the alarm persists, contact your service personnel.

The measurement time exceeds 120 seconds in the adult or pediatric mode, or exceeds 90 seconds in the neonatal mode, and the BP value cannot be obtained. Check the patient’s condition and NIBP connections, or replace the cuff and measure again.

The cuff type mismatches the patient category.

Verify the patient category or replace the cuff if necessary. If patient category is correct, check that the tubing is not bent and the airway is not occluded.

Airway leakage is found during the NIBP leakage test. Check the NIBP cuff and pump for leakages.

D.2.7

IBP Technical Alarm Messages

Alarm message

XX Sensor Error

XX No Sensor

Default priority

Med

Med

C

A

Indication on alarm reset

Cause and solution

The IBP sensor fails. Replace the sensor.

The IBP patient cable and/or corresponding IBP sensor is not connected or detached. Check the cable and sensor connection.

BeneVision N1 Patient Monitor Operator’s Manual D - 5

D.2.8

Alarm message Default priority

Indication on alarm reset

A

Cause and solution

XX No Pulse

XX Disconnected

Low

High

Host Monitor Version Low Low

C

A

The catheter may be occluded. Please flush the catheter.

The tubing is disconnected from the patient, or the three-way valve is open to the air. Check the connection of the tubing, or check the valve is open to the patient. If the alarm persists, contact your service personnel.

The N Series system software version is too low.

In order for the N Series monitor to connect to the N1 which connects to the external IBP module and perform IBP monitoring, the system software of N 1 and N series monitor should be

V01.11 and above.

Note: XX represents an IBP label, for example PA, CVP, FAP, P1, etc.

CO

2

Technical Alarm Messages

Alarm message

CO2 Module High Temp

Default priority

Low

Indication on alarm reset

C

CO2 Module Low Temp

CO2 Zero Failed

CO2 No Watertrap

CO2 No Adaptor

CO2 High Airway Press.

CO2 Low Airway Press.

Low

Low

Low

Low

Low

Low

C

C

B

B

C

C

Cause and solution

Ambient temperature is too high or there is a module failure.

1. Lower the operating temperature.

2. Reinsert the module.

3. If the alarm persists, the CO

2

module may have failed, contact your service personnel.

Ambient temperature is too low or there is a module failure.

1. Raise the operating temperature.

2. Reinsert the module.

3. If the alarm persists, the CO

2

module may have failed, contact your service personnel.

Reinsert the module. If the alarm persists, contact your service personnel.

Check the watertrap connections.

Check the adaptor connections.

1. Check the airway pressure settings of the ventilator/anesthesia machine.

2. Disconnect the module from the ventilator/ anesthesia machine.

3. Reinsert the module.

4. If the alarm persists, contact your service personnel.

1. Check the airway pressure settings of the ventilator/anesthesia machine.

2. Disconnect the module from the ventilator/ anesthesia machine.

3. Reinsert the module.

4. If the alarm persists, contact your service personnel.

D - 6 BeneVision N1 Patient Monitor Operator’s Manual

Alarm message

High Barometric

Low Barometric

CO2 Airway Occluded

CO2 No Filterline

CO2 Calibration Required

CO2 Airway Error

CO2 Adapter Error

CO2 No Sensor

CO2: Change Watertrap

CO2 Watertrap Mismatch

Default priority

Low

Indication on alarm reset

C

Low

Low

Low

Low

Low

Low

Low

Low

Low

C

C

A

C

C

A

A

C

C

Cause and solution

The ambient pressure exceeds the operating pressure range or CO

2

module fails.

1. Make sure that the ambient pressure meets the specifications, and check for sources that affect the ambient pressure.

2. Reinsert the module. If the alarm persists, contact your service personnel.

The ambient pressure exceeds the operating pressure range or CO

2

module fails.

1. Make sure that the ambient pressure meets the specifications, and check for sources that affect the ambient pressure.

2. Reinsert the module. If the alarm persists, contact your service personnel.

1. Check if the sample line is kinked or occluded.

2. Replace the sample line.

3. Reinsert the module.

4. If the alarm persists, contact your service personnel.

Make sure that the filterline is connected.

Perform a calibration.

1. Check if the sample line is kinked or occluded.

2. Replace the sample line.

3. Reinsert the module.

4. If the alarm persists, contact your service personnel.

Check, clean or replace the airway adapter.

Perform a zero calibration.

Make sure that the CO

2 transducer is connected.

Replace the watertrap.

Check the patient category and use a correct watertrap.

D.2.9

Power Supply Technical Alarm Messages

Alarm message

Low Battery

Critically Low Battery

Battery Service Required

Default priority

Med

Indication on alarm reset

C

High

Low

C

B

Power Board Comm Error

Battery Err

Battery Charging Error

High

High

High

C

C

C

Cause and solution

Connect the monitor to an AC power source and allow the batteries to charge.

Connect the monitor to an AC power source and allow the batteries to charge.

The battery has reached its lifetime. Contact the service personnel.

Shutdown and restart the monitor. If the alarm persists, contact your service personnel.

The battery may have failed. Contact your service personnel.

The charging circuit fails or the battery fails.

Contact your service personnel.

BeneVision N1 Patient Monitor Operator’s Manual D - 7

Alarm message Default priority

Indication on alarm reset

C Battery Temperature Too

High

Battery Off

High

High C

RT Clock Need Reset

RT Clock Not Exist

XX V Too High

XX V Too Low

High

High

High

High

Note: XX represents 2.5, 3.3, 5, or 12.

C

C

C

C

Cause and solution

Stop using the monitor after this alarm appears, and contact your service personnel.

Shutdown and restart the monitor. If the alarm persists, contact your service personnel.

Contact your service personnel.

Contact your service personnel.

There is a problem with the system power supply.

Shutdown and restart the monitor.

D.2.10

Printer Technical Alarm Messages

Alarm message

Printer Buffer Full

Printing Failed

Printing Stopped

Printer Unavailable

PDF storage space is nearly full

Error storing PDF file

Change the print server language to be consistent with this monitor

Default priority

Prompt

Indication on alarm reset

/

Prompt

Prompt

Prompt

Prompt

/

/

/

/

Prompt

Prompt

Print Server Disconnected Prompt

/

/

/

Cause and solution

The printer buffer is full. Wait until the printer finishes the printing task.

The printer ran out of paper or cannot be found on the network. Check the printer.

Printing was manually stopped.

The printer may have failed. Check the printer.

Delete the files saved under the PDF file path to release storage space. Otherwise you cannot save new PDF files.

The PDF file path settings on the print server and the PDF Creator are not consistent or the PDF storage space is full. Check the PDF file path settings for consistency, or delete the files saved under the PDF file path to release storage space.

Verify that the language settings of the print server and the monitor are consistent, Otherwise you cannot perform printing.

Check that the monitor is properly connected with the print server.

D.2.11

Technical Alarm Messages Related to Networked Monitoring

Alarm message

CMS/eGW Disconnected

Default priority

Low

Indication on alarm reset

B

View Bed XX YY-ZZ,

Network Disconnected.

Low A

Viewed by Bed XX YY-ZZ,

Network Disconnected.

Low

WLAN IP Address Conflict Low

A

C

Cause and solution

The monitor is disconnected from the CMS.

Check the network connection.

The network is interrupted when the monitor is viewing the remote device. Check the network connection.

The network is interrupted when the monitor is viewed by another remote device. Check the network connection.

There is a wireless network IP address conflicts.

Check the network settings.

D - 8 BeneVision N1 Patient Monitor Operator’s Manual

Alarm message Default priority

Indication on alarm reset

C

Cause and solution

LAN1 IP Address Conflict

Fail To Get WLAN IP

Address

Fail To Get LAN1 IP

Address

Low

Low

Low

C

C

There is a wired network IP address conflicts.

Check the network settings.

Unable to automatically obtain the wireless network IP address. Check the network settings.

Unable to automatically obtain the wired network IP address. Check the network settings.

Note: XX refers to the department name, YY refers to the room number, and ZZ refers to the bed number.

D.2.12

Other System Technical Alarm Messages

Alarm message

Storage Error

Loading Default Config

Failed

Read dock E2PROM error!

Default priority

High

Indication on alarm reset

C

Low

High

XX Conflicts

(XX refers to the module label)

XX Measurement has been closed

(XX refers to the module label)

The display setup for XX is disabled.

(XX refers to the parameter label)

Prompt

Prompt

Prompt

The patient data storage space is nearly full. Please delete some discharged patients.

Med

A

C

/

/

/

B

Cause and solution

The storage card failed or files are damaged.

Shutdown and restart the monitor. Format the storage card (CAUTION: this will clear all patient data stored on this monitor). If the alarm persists, contact your service personnel.

The default configuration was not correctly loaded. The monitor will restore to the factory default configuration for the current patient category.

1. Check if you’re using the specified external display.

• If you’re using the specified external display, remove the N1 from the Dock, and reconnect the N1 and the Dock.

• If you’re not using the specified external display, replace current external display with the specified external display. Then remove the N1 from the Dock, and reconnect the N1 and the Dock.

2. If the alarm persists, contact your service personnel.

The same type of corresponding module being used exceeds the supported number. Remove the conflict module.

The parameter module is disabled. Switch on the module if you want to use it. For more information, see

3.9.1 Switching On or Off a

Parameter

.

The parameter of the newly inserted module is not displayed on the screen. Select a desired area to display the parameter numerics and waveforms. For more information, see

3.9.2 Displaying Parameter Numerics and

Waveforms

.

The storage space of the monitor is full. Delete unnecessary discharged patients.

BeneVision N1 Patient Monitor Operator’s Manual D - 9

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D - 10 BeneVision N1 Patient Monitor Operator’s Manual

E

SpO

2

Sensor Accuracy

E.1

The Accuracy of Masimo SpO

2

Sensors

Table information for the plots below show A

RMS

values measured with Masimo SET Oximetry Technology in a clinical study.

Adtx/Pdtx/4000/4001

Inf/Neo/NeoPt/4002/4003/4004/4005

BeneVision N1 Patient Monitor Operator’s Manual E - 1

DCI/DCIP/4050/4051

LNCS YI

4053

E - 2 BeneVision N1 Patient Monitor Operator’s Manual

E.2

The Accuracy of Nellcor SpO

2

Sensors

SpO

2

Accuracy for Nellcor Sensors vs. Co-Oximeters (Arms)

SpO

2

Range

DS-100A

D-YS, OXI-P/I, OXI-A/N

MAXAI, MAXPI, MAXII

MAXNI

100% to 70%

1.64%

2.41%

1.62%

1.85%

100% to 90%

1.16%

1.38%

1.49%

1.71%

90% to 80%

1.67%

2.50%

1.57%

1.51%

80% to 70%

2.25%

3.60%

2.50%

1.59%

Modified Bland-Altman for SpO

2

- MAXAI, MAXPI, MAXII, MAXNI Sensors: (SpO

2 vs.SaO

2

- SaO

2

)

Modified Bland-Altman for SpO

2

- DS-100A Sensors: (SpO

2

- SaO

2

) vs.SaO

2

BeneVision N1 Patient Monitor Operator’s Manual E - 3

Modified Bland-Altman for SpO2 - D-YS, OXI-A/N, OXI-P/I Sensors: (SpO

2

- SaO

2

) vs.SaO

2

E - 4 BeneVision N1 Patient Monitor Operator’s Manual

F

Units, Symbols and Abbreviations

F.1

Units

Abbreviation mEq mg min ml mm m mAh

Mb mcg

L lb kg kPa in k h

Hz

°F g

GHz

GTT cc cm dB

DS

Ah bpm bps

°C

μs

A

μA

μV

BeneVision N1 Patient Monitor Operator’s Manual

In Full hour hertz inch kilo kilogram kilopascal litre pound meter milliampere hour mega byte microgram milli-equivalents milligram minute milliliter millimeter microampere microvolt microsecond

Ampere

Ampere hour beat per minute bits per second

Celsius cubic centimeter centimeter decibel dyne second

Fahrenheit gram gigahertz gutta

F - 1

F.2

Abbreviation s

V

VA

Ω

W mW

MΩ nm rpm mmHg cmH2O ms mV

Symbols

Symbol

%

/

×

©

±

In Full millimeters of mercury centimeters of water millisecond millivolt milliwatt megaohm nanometer breaths per minute second volt volt ampere ohm watt

Explanation negative, minus percent per; divide; or to plus equal to less than greater than less than or equal to greater than or equal to plus or minus multiply copyright

F - 2 BeneVision N1 Patient Monitor Operator’s Manual

F.3

Abbreviations

Abbreviation

C.I.

CIS

CISPR

CMOS

CMS

C.O.

CO

2

COHb

CAA

CaO

2

CCI

CCO

CCU

CE

CFI

Compl

CPI

CPO

CVP

DC

Des

BAP

BSA

BT

BTPS aVF aVL aVR awRR

AaDO

2

AC

Adu

AG

AHA

Ao

Art

ATMP

BeneVision N1 Patient Monitor Operator’s Manual

In Full alveolar-arterial oxygen gradient alternating current adult anaesthesia gas

American Heart Association aortic pressure arterial barometric pressure left foot augmented lead left arm augmented lead right arm augmented lead airway respiratory rate brachial arterial pressure body surface area blood temperature body temperature and pressure, saturated

Clinical Assistive Application arterial oxygen content continuous cardiac index continuous cardiac output cardiac (coronary) care unit

Conformité Européenne cardiac function index cardiac index clinical information system

International Special Committee on Radio Interference complementary metal oxide semiconductor central monitoring system cardiac output carbon dioxide carboxyhemoglobin compliance cardiac power index cardiac power output central venous pressure direct current desflurane

F - 3

F - 4

Abbreviation

FAP

FCC

FDA

Fi

FiAA

EtO

2

EVLW

ELWI

EWS

EtDes

EtEnf

EtHal

EtIso

EtSev

EtCO

2

EtN

2

O

EtO

ESVI

ESU

Et

EtAA

EMG

EMI

Enf

ESV

EDV

EEC

EEG

EMC

Dia dpi dPmx

DVI

DO

2

DO

2

I

ECG

In Full diastolic dot per inch left ventricular contractility digital video interface oxygen delivery oxygen delivery index electrocardiograph end-diastolic volume

European Economic Community electroencephalogram electromagnetic compatibility electromyograph electromagnetic interference enflurane end systolic volume end systolic volume index electrosurgical unit end-tidal end-tidal anesthetic agent end-tidal anesthetic agent end-tidal carbon dioxide end-tidal nitrous oxide ethylene oxide end-tidal oxygen extravascular lung water extravascular lung water index

Early Warning Score femoral arterial pressure

Federal Communication Commission

Food and Drug Administration fraction of inspired inspired anesthetic agent

BeneVision N1 Patient Monitor Operator’s Manual

Abbreviation

Iso

ITBI

ITBV

LA

I:E

IEC

IEEE

IP

ICP

ICT/B

ICU

ID

HIS

HR

IBP

IBW

LAP

LCD

LCW

LCWI

LDAP

LED

GEF

Hal

Hb

Hct

FV

GCS

GEDV

GEDI

FiDes

FiEnf

FiHal

FiIso

FiSev

FiCO2

FiN

2

O

FiO

2

FPGA

BeneVision N1 Patient Monitor Operator’s Manual

In Full inspired anesthetic agent fraction of inspired carbon oxygen fraction of inspired nitrous oxide fraction of inspired oxygen field programmable gate array flow-volume

Glasgow Coma Scale global end diastolic volume global end diastolic volume index global ejection fraction halothane hemoglobin haematocrit hospital information system heart rate invasive blood pressure ideal body weight intracranial pressure intracranial catheter tip pressure transducer intensive care unit identification inspiratory time: expiratory time ratio

International Electrotechnical Commission

Institute of Electrical and Electronic Engineers internet protocol isoflurane intrathoracic blood volume index intrathoracic blood volume left arm left atrial pressure liquid crystal display left cardiac work left cardiac work index

Lightweight Directory Access Protocol light emitting diode

F - 5

F - 6

Abbreviation

MEWS

MLDAP

MRI

MV

MVe

MVi

N/A

N

2

N

2

O

Neo

NEWS

NIBP

LL

LVET

LVSW

LVSWI

MAC

MAP

Mb

MetHb

Ped

PEEP

PEF

PEP

PIF

PIP

Pleth

Pmean

PO

2

Pplat

PPV

NIF

O

2

O

2

%

OR

OxyCRG

PA

Paw

PAWP

In Full left leg left ventricular ejection time left ventricular stroke work left ventricular stroke work index minimum alveolar concentration mean arterial pressure myoglobin methemoglobin

Modified Early Warning Score

Mindray LDAP, Mindray lightweight directory access protocol magnetic resonance imaging minute volume expiratory minute volume inspiratory minute volume not applied nitrogen nitrous oxide neonate

National Early Warning Score noninvasive blood pressure negative inspiratory force oxygen oxygen concentration operating room oxygen cardio-respirogram pulmonary artery airway pressure pulmonary artery wedge pressure pediatric positive end expiratory pressure peak expiratory flow pre-ejection period peak inspiratory flow peak inspiratory pressure plethysmogram mean pressure oxygen supply pressure plateau pressure pulse pressure variation

BeneVision N1 Patient Monitor Operator’s Manual

Abbreviation

TFT

TI

TRC

UAP

Sys

TB

TD

Temp

UPS

USB

SV

SVI

SVR

SVRI

SR

SSC

SSI

STR

SVV

SvO

2

Sync

RR

RSBI

RVEF

SOFA

SpO

2

SQI

Raw

Rec

Resp

RL

PR

PVC

PVPI

PVR

PVRI qSOFA

RA

RAP

BeneVision N1 Patient Monitor Operator’s Manual

In Full pulse rate premature ventricular contraction pulmonary vascular permeability index pulmonary vascular resistance pulmonary vascular resistance index quick Sepsis-Related Organ Failure Assessment right arm right atrial pressure airway resistance record, recording respiration right leg respiration rate rapid shallow breathing index right ventricular ejection fraction

Sepsis-Related Organ Failure Assessment arterial oxygen saturation from pulse oximetry signal quality index suppression ratio

Surviving Sepsis Campaign signal strength index systolic time ratio stroke volume stroke volume index systemic vascular resistance systemic vascular resistance index stroke volume variation venous oxygen saturation synchronization systolic pressure blood temperature temperature difference temperature thin-film technology injectate temperature tube resistance compensation umbilical arterial pressure uninterruptible power supply universal serial bus

F - 7

Abbreviation

UVP

VAC

VEPT

VPB

In Full umbilical venous pressure volts alternating current volume of electrically participating tissue ventricular premature beat per minute

F - 8 BeneVision N1 Patient Monitor Operator’s Manual

P/N: 046-011405-00(10.0)

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