MINDRAY

BeneVision N Series Operators Manual Rev 22.0

Operators Manual

570 Pages

File Type: PDF

File Size: 11.7 MB

File Name: MINDRAY - BeneVision N Series Operators Manual Rev 22.o - 2022-06.pdf

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Page 1

BeneVision N Series Patient Monitor

Operator’s Manual Volume I

(BeneVision N22/BeneVision N19/BeneVision N17/ BeneVision N15/BeneVision N12/BeneVision N12C)

This manual contains two volumes. Volume I contains safety information and introduction to the equipment. It tells you how to perform tasks other than parameter measurements and how to care for and maintain the equipment. Volume II tells you how to perform parameter-related measurements. It also lists parameter measurement specifications, alarms, and default settings.

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 copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights 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, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. is the registered trademarks or trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.

Responsibility on the Manufacturer Party Contents of this manual are subject to changes without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. 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;

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the electrical installation of the relevant room complies with the applicable national and local requirements;

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the product is used in accordance with the instructions for use.

WARNING

• This equipment must be operated by skilled/trained clinical professionals. • It is important for the hospital or organization that employs this equipment to carry out a

reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to ■

Malfunction or damage caused by improper use or man-made failure.

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Malfunction or damage caused by unstable or out-of-range power input.

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Malfunction or damage caused by force majeure such as fire and earthquake.

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Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.

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Malfunction of the instrument or part whose serial number is not legible enough.

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Others not caused by instrument or part itself.

Company Contact Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address

Mindray Building, Keji 12th Road South, High-tech Industrial Park, Nanshan, Shenzhen 518057, P.R.China

Website

www.mindray.com

E-mail Address:

[email protected]

Tel:

+86 755 81888998

Fax:

+86 755 26582680

EC-Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraβe 80, 20537 Hamburg, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

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 your product. If you have any question, please contact us. 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 critically ill patients.

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

Conventions

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

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

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→ is used to indicate operational procedures.

Contents Volume I 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 Intended Use ...2 - 1 2.2 Applied Parts ...2 - 1 2.3 System Components ...2 - 2 2.3.1 N22, N19 Main Unit ...2 - 2 2.3.2 N22, N19 Displays ...2 - 4 2.3.3 N17, N15, N12, N12C Main Unit ...2 - 7 2.3.4 Satellite Module Rack (SMR) ... 2 - 11 2.3.5 External Modules ... 2 - 11 2.3.6 Cable Management Kit ... 2 - 14 2.3.7 Input Devices ... 2 - 14 2.3.8 Printing Devices ... 2 - 14 3 Getting Started ... 3 - 1 3.1 Equipment Preparation Safety Information ...3 - 1 3.2 Monitor Installation ...3 - 1 3.2.1 Unpacking and Checking ...3 - 2 3.2.2 Environmental Requirements ...3 - 2 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 - 2 3.3.3 Connecting the SMR ...3 - 2 3.3.4 Connecting Modules to the Module Rack or SMR ...3 - 3 3.3.5 Removing Modules from the Module Rack or SMR ...3 - 3 3.4 Turning on the Monitor ...3 - 3 3.5 Operations on the Screen ...3 - 3 3.5.1 Using the Touchscreen ...3 - 4 3.5.2 Using the Navigation Knob (for N22/N19) ...3 - 4 3.5.3 Using the Barcode Reader ...3 - 4 3.5.4 Using the Remote Controller ...3 - 5 3.6 Screen Display ...3 - 5 3.6.1 On-screen Symbols ...3 - 6 3.6.2 Menus ...3 - 7 3.6.3 Quick Keys ...3 - 8 3.7 Operating Modes ... 3 - 10 3.7.1 Monitoring Mode ... 3 - 10

3.7.2 Privacy Mode ... 3 - 10 3.7.3 Night Mode ... 3 - 11 3.7.4 Standby Mode ... 3 - 12 3.8 Configuring Your Monitor ... 3 - 13 3.8.1 Setting the Screen Orientation (for N22 and N19) ... 3 - 13 3.8.2 Setting the Date and Time ... 3 - 13 3.8.3 Adjusting the Screen Brightness ... 3 - 14 3.8.4 Adjusting the Volume ... 3 - 14 3.8.5 Accessing the On-screen Guide ... 3 - 14 3.9 Starting Monitoring a Patient ... 3 - 14 3.10 Stopping a Parameter Measurement ... 3 - 14 3.11 General Operation ... 3 - 15 3.11.1 Switching On or Off a Parameter ... 3 - 15 3.11.2 Displaying Parameter Numerics and Waveforms ... 3 - 15 3.11.3 Displaying the Parameter List ... 3 - 15 3.11.4 Accessing Parameter Setup Menus ... 3 - 15 3.11.5 Changing Measurement Colors ... 3 - 16 3.12 Initiating a Manual Event ... 3 - 16 3.13 Using the On-Screen Timers ... 3 - 16 3.13.1 Displaying Timers ... 3 - 16 3.13.2 Controlling the Timer ... 3 - 16 3.13.3 Setting the Timer ... 3 - 17 3.14 Freezing Waveforms ... 3 - 17 3.14.1 Freezing Waveforms ... 3 - 17 3.14.2 Viewing Frozen Waveforms ... 3 - 17 3.14.3 Unfreezing Waveforms ... 3 - 18 3.14.4 Printing Frozen Waveforms ... 3 - 18 3.15 Using Secondary Displays ... 3 - 18 3.15.1 Connecting the Secondary Display Power Supply (for N22/N19) ... 3 - 18 3.15.2 Changing Secondary Display Settings ... 3 - 18 3.15.3 Setting the ECG Waveform Size for the Independent External Display (for N17/N15/N12) ... 3 - 18 3.16 Using the iView System ... 3 - 19 3.17 Using the nView Remote Displays ... 3 - 19 3.17.1 Recommended Hardware and Network Requirements ... 3 - 20 3.17.2 Installing the nView Tool ... 3 - 21 3.17.3 Manually Starting Remote Screen ... 3 - 21 3.17.4 Configuring the Remote Screen ... 3 - 21 3.17.5 Setting the ECG Waveform Size for the Remote Screen ... 3 - 22 3.17.6 Selecting a Different Monitor for nView ... 3 - 22 3.17.7 Restarting a Remote Screen ... 3 - 23 3.17.8 Closing Remote Screens ... 3 - 23 3.18 Capturing the Screen ... 3 - 23 3.19 Checking Software Licenses ... 3 - 23 3.20 Turning Off the Monitor ... 3 - 24 4 User Screens ...4 - 1 4.1 Choosing a Screen ...4 - 1 4.2 Setting Screens Switched by Swiping Across the Screen ...4 - 1 2

4.3 Normal Screen ...4 - 1 4.3.1 Entering the Normal Screen ...4 - 1 4.3.2 Configuring the Normal Screen ...4 - 1 4.4 The Big Numerics Screen ...4 - 1 4.4.1 Entering the Big Numerics Screen ...4 - 1 4.4.2 Configuring the Big Numerics Screen ...4 - 2 4.5 Minitrends Screen ...4 - 2 4.5.1 Entering the Minitrends Screen ...4 - 2 4.5.2 The Display of Minitrends Screen ...4 - 3 4.5.3 Viewing the Long Trends ...4 - 3 4.5.4 Setting Minitrends Parameters ...4 - 3 4.5.5 Setting the Minitrend Length ...4 - 3 4.5.6 Setting the Alarm Statistics Switch ...4 - 4 4.5.7 Setting the Alarm Statistics Duration ...4 - 4 4.5.8 Switching on the Routine Vital/Baseline Function ...4 - 4 4.6 The OxyCRG Screen ...4 - 5 4.6.1 Entering the OxyCRG Screen ...4 - 5 4.6.2 The Display of the OxyCRG Screen ...4 - 5 4.6.3 OxyCRG Events ...4 - 5 4.6.4 The Display of the ABD Event Area ...4 - 6 4.6.5 Setting OxyCRG Parameters ...4 - 6 4.6.6 Setting the Threshold of ABD Events ...4 - 6 4.6.7 Editing ABD Events ...4 - 6 4.7 The Targeted Goal Screen ...4 - 6 4.7.1 Entering the Targeted Goal Screen ...4 - 7 4.7.2 The Display of the Targeted Goal Screen ...4 - 7 4.7.3 Configuring the Targeted Goal Screen Layout ...4 - 7 4.7.4 Setting Parameter Statistics ...4 - 8 4.8 Remote View Screen ...4 - 9 4.8.1 Entering the Remote View Screen ...4 - 9 4.8.2 Adding a Bed ... 4 - 10 4.8.3 Removing a Bed ... 4 - 11 4.8.4 Displaying the Main Bed ... 4 - 11 4.8.5 Saving a Manual Event ... 4 - 11 4.8.6 Resetting Alarms for Remote Devices ... 4 - 11 4.8.7 Alarm Watch ... 4 - 11 4.8.8 Auto Displaying the New Alarm Bed ... 4 - 12 5 Managing Patients ... 5 - 1 5.1 Discharging a Patient ...5 - 1 5.1.1 Auto Discharging a Patient after Monitor Power Off ...5 - 1 5.1.2 Manually Discharging a Patient ...5 - 1 5.2 Admitting a Patient ...5 - 1 5.3 Managing Patient Information ...5 - 2 5.3.1 Entering the Patient Management Menu ...5 - 2 5.3.2 Editing Patient Information ...5 - 2 5.3.3 Loading Patient Information from the CMS ...5 - 2 5.3.4 Loading Patient Information from the ADT Server ...5 - 2 5.4 Transferring Patient ...5 - 3 3

5.4.1 Data Storage Introduction ...5 - 3 5.4.2 Transferring Patient Data ...5 - 4 5.5 Exporting Patient Data ...5 - 4 5.6 Deleting Patient Data ...5 - 4 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 - 2 6.3.3 Alarm Priority Escalation ...6 - 2 6.3.4 Alarm Indicators ...6 - 2 6.3.5 Alarm Status Symbols ...6 - 3 6.3.6 Highlighted Display of Alarm Messages ...6 - 3 6.4 iStatus Window ...6 - 4 6.5 Checking Physiological Alarm List ...6 - 4 6.6 Accessing On-screen Help for Technical Alarms (AlarmSight) ...6 - 4 6.7 Alarm Limits ...6 - 5 6.7.1 Auto Alarm Limits ...6 - 5 6.7.2 Initiating Auto Alarm Limits ...6 - 7 6.7.3 Guard Limit ...6 - 8 6.7.4 Alarm Limit Recommendations ...6 - 8 6.7.5 Restoring the Default Alarm Limits Settings ...6 - 9 6.8 Changing Alarm Settings ...6 - 9 6.8.1 Setting Parameter Alarm Properties ...6 - 9 6.8.2 Setting Alarm Tone Properties ...6 - 9 6.8.3 Enabling Special Alarm Sound ... 6 - 10 6.8.4 Setting the Alarm Delay Time ... 6 - 10 6.8.5 Setting the Apnea Delay Time ... 6 - 10 6.8.6 Adjusting the Alarm Light Brightness ... 6 - 11 6.8.7 Configuring Combined Alarms ... 6 - 11 6.8.8 Setting the Length of Printed Waveforms ... 6 - 11 6.8.9 Setting the Delay of SpO2 Low Alarm Escalation ... 6 - 11 6.8.10 Setting the Switch of the SpO2 Desat Alarm Off ... 6 - 12 6.8.11 Setting the Switch of the Apnea Alarm Off ... 6 - 12 6.9 Pausing Alarms/Pausing Alarm Tones ... 6 - 12 6.9.1 Defining the Pause Function ... 6 - 12 6.9.2 Pausing Alarms ... 6 - 12 6.9.3 Switching Off All Alarms ... 6 - 13 6.9.4 Pausing Alarm Sound ... 6 - 13 6.10 Resetting Alarms ... 6 - 14 6.10.1 Resetting Physiological Alarms ... 6 - 14 6.10.2 Resetting Technical Alarms ... 6 - 14 6.11 Latching Alarms ... 6 - 14 6.12 Nurse Call ... 6 - 14 6.13 Calling for Help ... 6 - 15 6.14 CPB Mode ... 6 - 15 4

6.14.1 Entering the CPB Mode ... 6 - 15 6.14.2 Exiting the CPB Mode ... 6 - 15 6.15 Intubation Mode ... 6 - 15 6.15.1 Entering the Intubation Mode ... 6 - 16 6.15.2 Exiting the Intubation Mode ... 6 - 16 6.16 Testing Alarms ... 6 - 16 6.17 Actions When an Alarm Occurs ... 6 - 16 7 Review ... 7 - 1 7.1 Review Overview ...7 - 1 7.2 Review Page ...7 - 1 7.2.1 Accessing the Review Page ...7 - 1 7.2.2 Example Review Page ...7 - 1 7.2.3 Symbols on Review Pages ...7 - 2 7.2.4 Common Operations ...7 - 2 7.2.5 Reviewing the Tabular Trends ...7 - 3 7.2.6 Reviewing the Graphics Trends ...7 - 4 7.2.7 Reviewing Events ...7 - 5 7.2.8 Reviewing Full Disclosure ...7 - 6 7.2.9 OxyCRG Review Page ...7 - 7 7.2.10 12-Lead ECG Review Page ...7 - 8 7.2.11 ST Review Page ...7 - 9 7.3 Reviewing Discharged Patients ... 7 - 10 7.3.1 Checking the Details of a Discharged Patient ... 7 - 10 7.3.2 Checking Patient Demographics of a Discharged Patient ... 7 - 10 8 Clinical Assistive Applications (CAA) ... 8 - 1 8.1 Glasgow Coma Scale (GCS) ...8 - 1 8.1.1 Displaying the GCS Parameter Area ...8 - 1 8.1.2 Accessing the GCS Menu ...8 - 2 8.1.3 Performing GCS Scoring ...8 - 2 8.1.4 Setting GCS Scoring Interval ...8 - 3 8.1.5 Reviewing GCS Trend Data ...8 - 3 8.2 SepsisSightTM ... 8 - 3 8.2.1 Accessing the SepsisSight Menu ...8 - 3 8.2.2 Screening ...8 - 3 8.2.3 Recommendations ...8 - 4 8.2.4 Reviewing SepsisSight Trend Data ...8 - 4 8.3 BoA Dashboard ...8 - 4 8.3.1 Opening the BoA Dashboard window ...8 - 5 8.3.2 BoA Dashboard Dispaly ...8 - 5 8.3.3 Aldrete Score ...8 - 6 8.3.4 Setting Parameter References ...8 - 6 8.3.5 Selecting Parameters for Anesthesia Status Indicator ...8 - 6 8.3.6 Setting Thresholds of Triple Low Parameters ...8 - 6 8.3.7 Setting BoA Dashboard Parameter Trends ...8 - 6 8.3.8 Setting the Locations of rSO2 Channels ...8 - 7 8.3.9 Restoring Default BoA Dashboard Settings ...8 - 7 8.4 Early Warning Score (EWS) ...8 - 7

8.4.1 Displaying the EWS Numerics Area ...8 - 8 8.4.2 Accessing the EWS Screen ...8 - 8 8.4.3 Performing EWS Scoring ...8 - 9 8.4.4 EWS Alarm ... 8 - 10 8.4.5 Changing EWS Settings ... 8 - 10 8.4.6 Viewing History Scores ... 8 - 11 8.4.7 Viewing Parameter Trends ... 8 - 12 8.5 Pace View ... 8 - 12 8.5.1 Accessing Pace View ... 8 - 12 8.5.2 Viewing the Current Pace Pulse ... 8 - 12 8.5.3 Viewing Historic Pace Events ... 8 - 12 8.6 InfusionView ... 8 - 13 8.6.1 Opening the InfusionView Window ... 8 - 13 8.6.2 InfusionView Display ... 8 - 13 8.6.3 Selecting InfusionView Trend Parameters ... 8 - 14 8.6.4 Changing the MiniTrend Length of InfusionView Parameters ... 8 - 14 8.7 NeuroSight ... 8 - 14 8.7.1 Opening the NeuroSight Window ... 8 - 14 8.7.2 NeuroSight Display ... 8 - 14 8.7.3 PRx ... 8 - 15 8.7.4 Setting the Locations of rSO2 Channels ... 8 - 15 8.7.5 Setting NeuroSight Parameter Trends ... 8 - 15 8.7.6 Setting PRx ... 8 - 16 8.7.7 Restoring Default NeuroSight Settings ... 8 - 16 8.8 Resus Mode ... 8 - 16 8.8.1 Entering the Resus Mode ... 8 - 16 8.8.2 CPR Record ... 8 - 16 8.8.3 Monitoring CPR Quality (CQI®) ... 8 - 18 8.8.4 Exiting the Resus Mode ... 8 - 19 8.8.5 Reviewing the Resuscitation Events ... 8 - 19 8.9 AF Summary ... 8 - 20 8.9.1 Opening the AF Summary Window ... 8 - 20 8.9.2 AF Summary Display ... 8 - 20 8.9.3 Setting A-Fib Statistical Duration ... 8 - 21 8.9.4 Setting Trend Parameters for the AF Summary ... 8 - 21 8.9.5 Setting the Type of Trend for the AF Summary ... 8 - 21 8.9.6 Printing the AF Summary Report ... 8 - 21 8.10 ECG 24h Summary ... 8 - 22 8.10.1 Opening the ECG 24h Summary Window ... 8 - 22 8.10.2 The Display of ECG 24h Summary ... 8 - 22 8.10.3 Selecting Typical ECG Strips ... 8 - 23 8.10.4 Setting the Statistical Duration of the ECG 24h Summary ... 8 - 23 8.10.5 Reviewing the ECG Summary ... 8 - 23 8.11 HemoSightTM ... 8 - 23 8.11.1 Accessing the HemoSight Menu ... 8 - 23 8.11.2 Viewing Hemodynamic Parameters ... 8 - 23 8.11.3 Physiology Graphics ... 8 - 28 8.11.4 Physiology Relationship ... 8 - 30 8.11.5 Decision Model (Only Available for PiCCO Module) ... 8 - 30

8.11.6 Hemodynamic Test ... 8 - 31 8.11.7 Following Up the Patient Hemodynamic Status ... 8 - 32 8.11.8 Evaluating the Hemodynamic Parameters ... 8 - 33 8.11.9 Changing Hemodynamic Parameter Settings ... 8 - 35 9 Calculation ... 9 - 1 9.1 Calculation Overview ...9 - 1 9.2 Calculation Safety Information ...9 - 1 9.3 Drug Calculations ...9 - 1 9.3.1 Performing Drug Calculations ...9 - 1 9.3.2 Checking the Titration Table ...9 - 2 9.3.3 Drug Calculation Formula ...9 - 2 9.3.4 Titration Table Calculation Formula ...9 - 2 9.4 Hemodynamic Calculations ...9 - 3 9.4.1 Performing Hemodynamic Calculations ...9 - 3 9.4.2 Input Parameters for Hemodynamic Calculations ...9 - 3 9.4.3 Calculated Parameters and Formulas for Hemodynamic Calculations ...9 - 3 9.5 Oxygenation Calculations ...9 - 4 9.5.1 Performing Oxygenation Calculations ...9 - 4 9.5.2 Input Parameters for Oxygenation Calculations ...9 - 5 9.5.3 Calculated Parameters and Formulas for Oxygenation Calculations ...9 - 5 9.6 Ventilation Calculations ...9 - 6 9.6.1 Performing Ventilation Calculations ...9 - 6 9.6.2 Input Parameters for Ventilation Calculations ...9 - 6 9.6.3 Calculated Parameters and Formulas for Ventilation Calculations ...9 - 6 9.7 Renal Calculations ...9 - 7 9.7.1 Performing Renal Calculations ...9 - 7 9.7.2 Calculated Parameters and Formulas for Renal Calculations ...9 - 7 9.7.3 Calculated Parameters and Formulas for Renal Calculations ...9 - 8 10 Recording ...10 - 1 10.1 Recorder ... 10 - 1 10.2 Starting Recordings ... 10 - 1 10.2.1 Manually Starting Recordings ... 10 - 1 10.2.2 Automatic Recordings ... 10 - 1 10.3 Stopping Recordings ... 10 - 2 10.3.1 Stopping Recordings Manually ... 10 - 2 10.3.2 Stopping Recordings Automatically ... 10 - 2 10.4 Recording Related Flags ... 10 - 2 10.5 Setting the Recorder ... 10 - 2 10.6 Enabling Auto Recording on Alarm ... 10 - 2 10.7 Clearing Recording Tasks ... 10 - 3 10.8 Loading Paper ... 10 - 3 10.9 Removing Paper Jam ... 10 - 4 11 Printing ...11 - 1 11.1 Supported Printer ... 11 - 1

11.2 End Case Reports ... 11 - 1 11.2.1 Printing the End Case Report ... 11 - 1 11.2.2 Setting a Report as An End Case Report ... 11 - 1 11.2.3 Setting the End Case Report ... 11 - 2 11.2.4 Setting the End Case Report Period ... 11 - 2 11.3 Manually Starting a Printing Task ... 11 - 2 11.3.1 Starting Printing from the Current Page ... 11 - 2 11.3.2 Printing Realtime Reports ... 11 - 2 11.3.3 Printing Common Reports ... 11 - 2 11.4 Automatically Printing Reports ... 11 - 2 11.5 Stopping a Printing Task ... 11 - 3 11.6 Setting Reports ... 11 - 3 11.6.1 Setting ECG Reports ... 11 - 3 11.6.2 Setting Realtime Reports ... 11 - 4 11.6.3 Setting Tabular Trends Reports ... 11 - 4 11.6.4 Setting Graphic Trends Reports ... 11 - 4 11.7 Viewing Printer Status ... 11 - 5 11.8 Printer Out of Paper ... 11 - 5 12 Managing Configurations ...12 - 1 12.1 Configuration Introduction ... 12 - 1 12.2 Changing the Department ... 12 - 1 12.3 Setting Default Patient Category ... 12 - 1 12.4 Setting Default Configuration ... 12 - 1 12.5 Defining Age Segments ... 12 - 2 12.6 Saving Current Settings ... 12 - 2 12.7 Deleting a Configuration ... 12 - 2 12.8 Transferring a Configuration ... 12 - 3 12.8.1 Exporting a Configuration ... 12 - 3 12.8.2 Importing a Configuration ... 12 - 3 12.9 Printing Configurations ... 12 - 3 12.10 Loading a Configuration ... 12 - 3 12.11 Modifying Configuration Password ... 12 - 4 13 User Maintenance Settings ...13 - 1 13.1 Accessing the Maintenance Menu ... 13 - 1 13.2 The Device Location Settings ... 13 - 1 13.3 The Patient Management Settings ... 13 - 2 13.3.1 The Field Tab ... 13 - 2 13.3.2 The Find Patient Tab ... 13 - 2 13.3.3 The Transfer Tab ... 13 - 3 13.3.4 The Discharge Tab ... 13 - 3 13.3.5 The Location Tab ... 13 - 4 13.3.6 The Display Tab ... 13 - 4 13.4 The Alarm Settings ... 13 - 4 13.4.1 The Audio Tab ... 13 - 4 13.4.2 The Pause/Reset Tab ... 13 - 5 8

13.4.3 The Latching Tab ... 13 - 6 13.4.4 The Guard Limits Tab ... 13 - 6 13.4.5 The Combined Alarm Tab ... 13 - 7 13.4.6 The Remote View Tab ... 13 - 7 13.4.7 The Nurse Call Tab ... 13 - 8 13.4.8 The Other Tab ... 13 - 9 13.5 The CAA Settings ...13 - 10 13.5.1 The EWS Tab ...13 - 10 13.5.2 The GCS Tab ...13 - 10 13.5.3 The SepsisSight Tab ...13 - 10 13.6 The Module Settings ...13 - 10 13.6.1 The ECG Tab ...13 - 10 13.6.2 The CO2 Tab ...13 - 11 13.6.3 The AG Tab ...13 - 11 13.6.4 The Other Tab ...13 - 12 13.7 The Review Settings ...13 - 12 13.7.1 The Tabs Tab ...13 - 12 13.7.2 The Event Tab ...13 - 12 13.7.3 The Arrhy Mark Tab ...13 - 13 13.7.4 The Export Tab ...13 - 13 13.8 The Display Settings ...13 - 13 13.9 The Print Settings ...13 - 13 13.9.1 The Printer Tab ...13 - 13 13.9.2 The Report Layout Tab ...13 - 14 13.9.3 The ECG Report Tab ...13 - 14 13.9.4 The PDF File Name Tab ...13 - 15 13.9.5 The Other Tab ...13 - 15 13.10 The Unit Settings ...13 - 15 13.11 The Time Settings ...13 - 15 13.11.1 The Time Synchronization Tab ...13 - 15 13.11.2 The Daylight Savings Time Tab ...13 - 16 13.12 The Other Settings ...13 - 16 13.13 The Authorization Setup Settings ...13 - 17 13.14 The Version Settings ...13 - 19 13.15 The Battery Information Settings ...13 - 19 13.16 The Scanner Settings ...13 - 19 13.16.1 The 2D Barcode Tab (for the Mindray Custom 2D Barcode Reader) ...13 - 19 13.16.2 The 1D Barcode Tab ...13 - 19 13.16.3 The Scanner Information Tab ...13 - 19 13.16.4 The Identify Scanner Tab (for the non-Mindray Custom 2D Barcode Reader) ...13 - 20 13.16.5 The Field Tab (for the Mindray Custom 2D Barcode Reader) ...13 - 20 13.17 The Network Setup Settings ...13 - 20 13.17.1 The Network Type Tab ...13 - 20 13.17.2 The LAN1 IP Tab ...13 - 20 13.17.3 The WLAN Tab ...13 - 21 13.17.4 The Central Station Setup Tab ...13 - 21 13.17.5 The Device Discover Tab ...13 - 22 13.17.6 The QoS Tab ...13 - 22 9

13.17.7 The ADT Tab ...13 - 22 13.17.8 The HL7 Configuration Tab ...13 - 22 13.17.9 The Information Security Tab ...13 - 23 13.17.10 The MLDAP Tab ...13 - 23 14 Networked Monitoring ...14 - 1 14.1 Network Introduction ... 14 - 1 14.2 Network Safety Information ... 14 - 1 14.3 Connecting the Monitor to the CMS ... 14 - 1 14.4 Connecting the eGateway ... 14 - 2 14.5 MLDAP ... 14 - 2 14.6 Connecting the Wireless Network ... 14 - 2 14.7 Disconnecting the Wireless Network ... 14 - 2 15 Using with the Telemetry Monitor ...15 - 1 15.1 Introduction ... 15 - 1 15.1.1 Pairing Procedure ... 15 - 1 15.2 Binding the Telemetry with the Monitor ... 15 - 2 15.3 Unpairing the Telemetry and the Monitor ... 15 - 2 15.3.1 Unpairing the Telemetry and the Monitor via the Monitor ... 15 - 2 15.3.2 Unpairing the Telemetry and the Monitor via the telemetry ... 15 - 2 15.4 Troubleshooting ... 15 - 3 16 Interfacing with External Devices ...16 - 1 16.1 Device Integration Safety Information ... 16 - 1 16.2 Connecting External Devices By Using the BeneLink Module ... 16 - 1 16.3 Connecting External Devices through Wired or Wireless Network ... 16 - 2 16.4 Connecting External Devices by Using the Monitor as a Hotspot ... 16 - 3 16.5 Differences in Displayed Values ... 16 - 3 16.6 Accessing the Integrated Devices Screen ... 16 - 4 16.6.1 Setting Parameters from External Devices for Display ... 16 - 4 16.6.2 Setting Alarms from External Devices ... 16 - 4 16.6.3 Setting Units for Parameters from External Devices ... 16 - 5 16.7 Displaying Data from External Devices on the Main Screen ... 16 - 5 16.7.1 Setting Waveform Properties for Parameters from External Devices ... 16 - 5 16.7.2 Selecting Measured Parameters from the Anesthesia System for Display ... 16 - 5 16.8 Entering the Loops Screen ... 16 - 6 16.9 Viewing Infusion Details Screen ... 16 - 6 16.10 Viewing Alarms from External Devices ... 16 - 6 16.11 Viewing Parameter Trends from External Devices ... 16 - 6 16.12 Recording and Printing Parameter Trends from External Devices ... 16 - 6 17 Battery ...17 - 1 17.1 Battery Introduction ... 17 - 1 17.2 Battery Safety Information ... 17 - 1 17.3 Installing or Replacing the Battery ... 17 - 1

17.4 Battery Indications ... 17 - 2 17.4.1 Battery LED ... 17 - 2 17.4.2 Battery Symbols ... 17 - 3 17.4.3 Battery-related Alarms ... 17 - 3 17.5 Charging the Battery ... 17 - 3 17.6 Maintaining the Battery ... 17 - 3 17.6.1 Conditioning the Battery ... 17 - 3 17.6.2 Checking Battery Performance ... 17 - 3 17.7 Storing Batteries ... 17 - 4 17.8 Recycling Batteries ... 17 - 4 18 Care and Cleaning ...18 - 1 18.1 Care and Cleaning Introduction ... 18 - 1 18.2 Care and Cleaning Safety Information ... 18 - 1 18.3 Cleaning the Monitor/Module/SMR ... 18 - 1 18.4 Disinfecting the Monitor/Module/SMR ... 18 - 2 18.5 Cleaning and Disinfecting the Accessories ... 18 - 4 18.5.1 Cleaning the Accessories ... 18 - 4 18.5.2 Disinfecting the Accessories ... 18 - 4 18.6 Sterilization... 18 - 8 18.7 Cleaning the Thermal Print Head ... 18 - 8 18.8 Impact of Improper Cleaning ... 18 - 9 19 Maintenance ...19 - 1 19.1 Maintenance Introduction ... 19 - 1 19.2 Maintenance Safety Information ... 19 - 1 19.3 Maintenance and Testing Schedule ... 19 - 2 19.4 Checking Version Information ... 19 - 2 19.5 Testing Methods and Procedures ... 19 - 2 19.5.1 Performing Visual Inspection ... 19 - 3 19.5.2 Performing Power-on Test ... 19 - 3 19.5.3 Checking the NMT Sensor ... 19 - 3 19.5.4 Testing the Recorder ... 19 - 3 19.5.5 Testing the Network Printer ... 19 - 3 19.5.6 Checking the Battery ... 19 - 4 19.6 Disposing of the Monitor ... 19 - 4 A Product Specifications ...A - 1 A.1 Monitor Safety Specifications ... A - 1 A.2 Physical Specifications ... A - 1 A.2.1 BeneVision N22/N19 ... A - 1 A.2.2 BeneVision N17/N15/N12/N12C ... A - 1 A.2.3 SMR and Modules ... A - 2 A.3 Environmental Specifications ... A - 3 A.4 Power Supply Specifications ... A - 4 A.4.1 External Power Supply Specifications ... A - 4 A.4.2 Battery Specifications ... A - 4

A.5 Display Specifications ... A - 5 A.6 Touchscreen Specifications ... A - 5 A.7 Recorder Specifications ... A - 5 A.8 LEDs ... A - 5 A.9 Audio Indicator ... A - 6 A.10 Monitor Interface Specifications ... A - 6 A.10.1 Interface Specifications of the N22/N19 Main Unit ... A - 6 A.10.2 Interface Specifications of the N22/N19 Separate Primary Display ... A - 6 A.10.3 Interface Specifications of the N22/N19 Integrated Primary Display ... A - 6 A.10.4 Interface Specifications of the N22/N19 Secondary Display ... A - 6 A.10.5 Interface Specifications of the N17/N15/N12/N12C ... A - 7 A.11 Signal Outputs Specifications ... A - 7 A.12 Data Storage ... A - 8 A.13 Wi-Fi Specifications ... A - 8 A.13.1 Wi-Fi Technical Specifications (MSD45N) ... A - 8 A.13.2 Wi-Fi Technical Specifications (SX-SDMAC-2832S+) ... A - 8 A.13.3 Wi-Fi Performance Specifications ... A - 9 B EMC and Radio Regulatory Compliance ...B - 1 B.1 EMC ...B - 1 B.2 Radio Regulatory Compliance ...B - 4 C Electrical Safety Inspection ...C - 1 C.1 Power Cord Plug ...C - 1 C.2 Device Enclosure and Accessories ...C - 1 C.2.1 Visual Inspection ...C - 1 C.2.2 Contextual Inspection ...C - 2 C.3 Device Labeling ...C - 2 C.4 Protective Earth Resistance ...C - 2 C.5 Earth Leakage Test ...C - 2 C.6 Patient Leakage Current ...C - 3 C.7 Mains on Applied Part Leakage ...C - 3 C.8 Patient Auxiliary Current ...C - 4 D ECG Wave Recognition Method for Mindray Resting 12-lead ECG Analysis Algorithm ... D - 1 D.1 Preprocessing ... D - 1 D.2 QRS typing ... D - 1 D.3 Selection of required QRS class ... D - 1 D.4 Averaging ... D - 1 D.5 Wave measurement ... D - 1 D.6 QRS components ... D - 1 D.7 ST segment ... D - 1 D.8 P and T waves ... D - 2 D.9 Evaluation results of absolute interval and wave duration measurements ... D - 2 D.10 Evaluation results of interval measurements on biological ECGs ... D - 2 D.11 Evaluation results of stability of measurements against noise ... D - 2

E Abbreviations ... E - 1 F Declaration of Conformity ... F - 1

Volume II 20 Monitoring ECG, Arrhythmia, ST and QT ...20 - 1 20.1 ECG Introduction ... 20 - 1 20.2 ECG Safety Information ... 20 - 1 20.3 ECG Display ... 20 - 2 20.4 Preparing for ECG Monitoring ... 20 - 3 20.4.1 Preparing the Patient Skin ... 20 - 3 20.4.2 Applying Electrodes ... 20 - 3 20.4.3 Lead Wire Color Code ... 20 - 4 20.4.4 ECG Electrode Placement ... 20 - 4 20.4.5 Choosing the ECG Lead Type ... 20 - 6 20.4.6 Checking Paced Status ... 20 - 6 20.4.7 Enabling Pacer Rejection ... 20 - 6 20.5 Using 6-lead Placement to Derive 12-lead ECG (D12L) ... 20 - 7 20.6 Changing ECG Settings ... 20 - 7 20.6.1 Choosing an ECG Screen ... 20 - 7 20.6.2 Setting ECG Alarm Properties ... 20 - 8 20.6.3 Setting the Analysis Mode ... 20 - 8 20.6.4 Changing ECG Wave Settings ... 20 - 8 20.6.5 Disabling the Smart Lead Off Function ...20 - 10 20.6.6 Disabling the CrozFusionTM Function ...20 - 10 20.6.7 Adjusting the QRS Volume ...20 - 10 20.6.8 Adjusting the Minimum QRS Detection Threshold ...20 - 11 20.7 Monitoring Arrhythmia ...20 - 11 20.7.1 Arrhythmia Safety Information ...20 - 11 20.7.2 Arrhythmia Events ...20 - 11 20.7.3 Displaying Arrhythmia Information ...20 - 13 20.7.4 Changing Arrhythmia Settings ...20 - 13 20.7.5 Deactivated Arrhythmia Alarms ...20 - 15 20.8 ST Segment Monitoring ...20 - 17 20.8.1 ST Safety Information ...20 - 17 20.8.2 Enabling ST Monitoring ...20 - 18 20.8.3 Displaying ST Numerics ...20 - 18 20.8.4 Displaying ST Segments in the Waveform Area ...20 - 19 20.8.5 Entering the ST View ...20 - 19 20.8.6 Saving the Current ST as Baseline ...20 - 19 20.8.7 Entering the ST Graphic Window ...20 - 20 20.8.8 Changing ST Settings ...20 - 21 20.8.9 ST Point, ISO Point, and J Point ...20 - 21 20.8.10 Setting ST Point, ISO Point, and J Point ...20 - 22 20.9 QT/QTc Interval Monitoring ...20 - 22 20.9.1 QT/QTc Monitoring Limitations ...20 - 22 20.9.2 Enabling QT/QTc Monitoring ...20 - 22 20.9.3 Displaying QT/QTc Numerics and Segments ...20 - 23 20.9.4 Entering the QT View ...20 - 23

20.9.5 Saving the Current QTc as Baseline ...20 - 24 20.9.6 Changing QT Settings ...20 - 24 20.10 ECG Relearning ...20 - 25 20.10.1 Auto ECG Relearning ...20 - 25 20.10.2 Manually Initiating an ECG Relearning ...20 - 25 20.11 Calibrating ECG ...20 - 25 20.12 Defibrillation Synchronization Pulse Output ...20 - 25 20.13 ECG Troubleshooting ...20 - 26 21 Resting 12-Lead ECG Analysis ...21 - 1 21.1 Resting 12-Lead ECG Analysis Introduction ... 21 - 1 21.2 Entering the 12-Lead Screen ... 21 - 1 21.3 Initiating Resting 12-Lead ECG Analysis ... 21 - 1 21.4 Changing 12-Lead ECG Analysis Settings ... 21 - 1 21.4.1 Setting the High Frequency Filter ... 21 - 1 21.4.2 Setting the Baseline Drift Removal ... 21 - 2 21.5 Glasgow Resting 12-lead ECG Analysis Algorithm Settings ... 21 - 2 21.5.1 Editing Patient Information (For Glasgow Algorithms) ... 21 - 2 21.5.2 Setting Tachycardia and Bradycardia Thresholds (For Glasgow Algorithms) ... 21 - 2 21.5.3 Setting the 12-Lead Interpretation Report (For Glasgow Algorithms) ... 21 - 2 21.6 Saving the 12-Lead Interpretation Report ... 21 - 3 21.7 Printing the 12-Lead Interpretation Report ... 21 - 3 21.8 Exiting the ECG 12-Lead Screen ... 21 - 3 22 Monitoring Respiration (Resp) ...22 - 1 22.1 Resp Introduction ... 22 - 1 22.2 Resp Safety Information ... 22 - 1 22.3 Resp Display ... 22 - 1 22.4 Preparing for Resp Monitoring ... 22 - 2 22.4.1 Preparing the Patient ... 22 - 2 22.4.2 Placing the Electrodes ... 22 - 2 22.5 Changing Resp Settings ... 22 - 3 22.5.1 Setting the Resp Alarm Properties ... 22 - 3 22.5.2 Setting the RR Source ... 22 - 3 22.5.3 Choosing the Respiration Lead ... 22 - 3 22.5.4 Setting the Resp Waveform Size ... 22 - 3 22.5.5 Setting the Resp Waveform Speed ... 22 - 3 22.5.6 Setting the Auto Detection Switch ... 22 - 4 22.5.7 Manually Adjusting the Resp Waveform Detection Threshold ... 22 - 4 22.6 Resp Troubleshooting ... 22 - 4 23 Monitoring Pulse Oxygen Saturation (SpO2) ...23 - 1 23.1 SpO2 Introduction ... 23 - 1 23.2 SpO2 Safety Information ... 23 - 2 23.3 SpO2 Measurement Limitations ... 23 - 3 23.4 SpO2 Display ... 23 - 4 23.5 Preparing for SpO2 Monitoring ... 23 - 4 14

23.6 Changing the SpO2 Settings ... 23 - 5 23.6.1 Changing the SpO2 Alarm Settings ... 23 - 5 23.6.2 Monitoring SpO2 and NIBP Simultaneously ... 23 - 5 23.6.3 Sat-Seconds Alarm Management (for Nellcor SpO2) ... 23 - 5 23.6.4 Setting the SpO2 Sat-Seconds (for Nellcor SpO2) ... 23 - 6 23.6.5 Setting SpO2 Sensitivity (for Masimo SpO2) ... 23 - 6 23.6.6 Enabling FastSAT (for Masimo SpO2) ... 23 - 7 23.6.7 Displaying SIQ (for Masimo SpO2) ... 23 - 7 23.6.8 Changing Averaging Time (for Masimo SpO2) ... 23 - 7 23.6.9 Changing the Sensitivity (for Mindray SpO2) ... 23 - 8 23.6.10 Showing/Hiding PI ... 23 - 8 23.6.11 Changing the Sweep Speed of the Pleth Wave ... 23 - 8 23.7 Changing the PR Settings ... 23 - 8 23.7.1 Changing the PR Alarm Settings ... 23 - 8 23.7.2 Changing the QRS Volume ... 23 - 8 23.7.3 Setting the PR Source ... 23 - 8 23.7.4 Showing/Hiding PR ... 23 - 9 23.8 SpO2 Troubleshooting ... 23 - 9 23.9 Nellcor Information ...23 - 10 23.10 Masimo Information ...23 - 10 23.11 Masimo End-User License Agreement ...23 - 10 24 Monitoring Temperature (Temp) ...24 - 1 24.1 Temperature Introduction ... 24 - 1 24.2 Displaying the Temp Numerics Area ... 24 - 1 24.3 Temperature Display (for MPM and Temp Module) ... 24 - 2 24.4 Preparing for Temperature Monitoring (for MPM and Temp Module) ... 24 - 2 24.5 Changing Temperature Settings (for MPM and Temp Module) ... 24 - 2 24.5.1 Setting the Temperature Alarm Properties (for MPM and Temp Module) ... 24 - 2 24.5.2 Selecting the Temperature Label (for MPM and Temp Module) ... 24 - 2 24.5.3 Displaying the Temperature Difference (for MPM and Temp Module) ... 24 - 2 24.6 Monitoring Temperature with GeniusTM Tethered Tympanic Thermometer ... 24 - 3 24.6.1 Tympanic Temperature Display ... 24 - 3 24.6.2 Measuring the Tympanic Temperature ... 24 - 3 24.7 Temperature Troubleshooting ... 24 - 4 25 Monitoring Noninvasive Blood Pressure (NIBP) ...25 - 1 25.1 NIBP Introduction ... 25 - 1 25.2 NIBP Safety Information ... 25 - 1 25.3 NIBP Measurement Limitations ... 25 - 2 25.4 Measurement Modes ... 25 - 2 25.5 NIBP Display ... 25 - 2 25.6 Preparing for NIBP Measurements ... 25 - 3 25.6.1 Preparing the Patient for NIBP Measurements ... 25 - 3 25.6.2 Placing the NIBP Cuff ... 25 - 3 25.7 Starting and Stopping NIBP Measurements ... 25 - 4 25.8 Changing NIBP Settings ... 25 - 5

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